CURE CATHETER HM14CRecalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00815947020345), received between Aug 23, 2019 and May 7, 2026 — classified as 15 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (48 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Packaging Problem

  END USER REPORTS PAPER THIN AND RIPPING WITH UNKNOWN QTY, FROM UNKNOWN MUS AND UNKNOWN LOTS. ADDITIONALLY REPORTS PAPER THIN AND RIPPING WITH THE MAJORITY OF CATHETERS (UNKNOWN QTY) FROM CURRENT MU'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117742 ↗
• MalfunctionMay 7, 2026Packaging Problem

  END USER REPORTS WATER SACHET STICKING IN PACKAGING AND RIPPING PAPER WITH CURRENT 2 MU'S. HE REPORTS MAJORITY OF CATHETERS (UNKNOWN QTY) AFFECTED. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED. THIS EMDR IS TO ADDRESS THE UNKNOWN MARKET UNITS/LOT #'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117701 ↗
• MalfunctionMay 7, 2026Packaging Problem

  END USER REPORTS WATER SACHET STICKING IN PACKAGING AND RIPPING PAPER WITH CURRENT 2 MU'S. HE REPORTS MAJORITY OF CATHETERS (UNKNOWN QTY) AFFECTED. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117693 ↗
• MalfunctionMay 6, 2026Packaging Problem

  END USER REPORTS PAPER THIN AND RIPPING WITH UNKNOWN QTY, FROM UNKNOWN MUS AND UNKNOWN LOTS. ADDITIONALLY REPORTS PAPER THIN AND RIPPING WITH THE MAJORITY OF CATHETERS (UNKNOWN QTY) FROM CURRENT MU'S. THIS EMDR IS TO ADDRESS THE UNKNOWN MARKET UNITS/LOT # S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095588 ↗
• InjuryNov 26, 2025Device Handling Problem; Device Handling Problem

  CONSUMER REPORTS "USING THIS PRODUCT FOR ABOUT 4 YRS NOW ADVISED TO CATH 4 X A DAY, SOMETIMES WILL ONLY CATH 3 X HE SAID. HE HAS RETENTION FROM AN ¿OVERSTRETCHED¿ BLADDER CAUSED BY BPH. HE STATES HE HAS NEVER CHANGED HOW HE HAS USED THIS PRODUCT IN ALL THE YEARS HE HAS USED IT. HE ALWAYS BREAKS WATER PACKET TO PREP CATHETER AND DOESN'T TOUCH THE CATHETER ITSELF AND ALWAYS USES THE NO TOUCH SLEEVE. HE SUSPECTS WE HAVE CHANGED THE WAY WE MANUFACTURE THIS ITEM IN SOME WAY CAUSING HIM TO GET MULTIPLE UTIS. HE COULD NOT PINPOINT ANYTHING, HOWEVER, CONCERNED ABOUT STERILITY OF THEM DUE TO HIS UTIS. CONSUMER UPSET SAYING VARIOUS TIMES HE HAS NEVER, IN 4 YRS, CHANGED HOW HE HAS USED THIS PRODUCT AND ONLY STARTING A YEAR AGO, HE STARTED GETTING MULTIPLE UTIS THAT IS WHY HE FEELS IT IS THE PRODUCT THAT IS TO BLAME. HE FEELS LIKE THIS PRODUCT IS THE CAUSE FOR HIS UTIS. HE DOES NOT HAVE ANY DIFFICULTY PASSING THEM. IN DISCUSSING HIS TYPICAL ROUTINE FOR INTERMITTENT CATHETERIZATION, HE ADMITTED HE SOMETIMES DOESN'T WASH HIS HANDS AND DOES NOT EVER CLEANSE MEATUS PRIOR TO INSERTING CATHETER AT ALL." IT WAS EXPLAINED "THE IMPORTANCE OF BOTH FOR UTI PREVENTION WHEN PERFORMING INTERMITTENT CATHETER

  Patient problems: Urinary Tract Infection

  MAUDE report 23657687 ↗
• InjuryNov 26, 2025Device Handling Problem; Device Handling Problem

  CONSUMER REPORTS "USING THIS PRODUCT FOR ABOUT 4 YRS NOW ADVISED TO CATH 4 X A DAY, SOMETIMES WILL ONLY CATH 3 X HE SAID. HE HAS RETENTION FROM AN ¿OVERSTRETCHED¿ BLADDER CAUSED BY BPH. HE STATES HE HAS NEVER CHANGED HOW HE HAS USED THIS PRODUCT IN ALL THE YEARS HE HAS USED IT. HE ALWAYS BREAKS WATER PACKET TO PREP CATHETER AND DOESN¿T TOUCH THE CATHETER ITSELF AND ALWAYS USES THE NO TOUCH SLEEVE. HE SUSPECTS WE HAVE CHANGED THE WAY WE MANUFACTURE THIS ITEM IN SOME WAY CAUSING HIM TO GET MULTIPLE UTIS. HE COULD NOT PINPOINT ANYTHING, HOWEVER, CONCERNED ABOUT STERILITY OF THEM DUE TO HIS UTIS. CONSUMER UPSET SAYING VARIOUS TIMES HE HAS NEVER, IN 4 YRS, CHANGED HOW HE HAS USED THIS PRODUCT AND ONLY STARTING A YEAR AGO, HE STARTED GETTING MULTIPLE UTIS THAT IS WHY HE FEELS IT IS THE PRODUCT THAT IS TO BLAME. HE FEELS LIKE THIS PRODUCT IS THE CAUSE FOR HIS UTIS. HE DOES NOT HAVE ANY DIFFICULTY PASSING THEM. IN DISCUSSING HIS TYPICAL ROUTINE FOR INTERMITTENT CATHETERIZATION, HE ADMITTED HE SOMETIMES DOESN¿T WASH HIS HANDS AND DOES NOT EVER CLEANSE MEATUS PRIOR TO INSERTING CATHETER AT ALL." IT WAS EXPLAINED "THE IMPORTANCE OF BOTH FOR UTI PREVENTION WHEN PERFORMING INTERMITTENT CATHETER

  Patient problems: Urinary Tract Infection

  MAUDE report 23657686 ↗
• MalfunctionAug 29, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22922863 ↗
• InjuryJul 10, 2025Device Handling Problem; Device Handling Problem

  END USER REPORTED BLEEDING AND UROSEPSIS WHEN USING THE HM14C CATHETER. THE END USER "CATHS 8 - 10 TIMES A DAY. HE HAS CATHED FOR 23 YRS AND PRIMARILY USED THE STRIAGHT TIP HM14 CATHETER AND IT HAS ALWAYS WORKED VERY WELL FOR HIM. HE SAID HE DOESN'T GET UTIS OFTEN, MAYBE WILL GET THE AVERAGE 1- 2 UTIS PER YEAR." HE SAID HE WAS RECENTLY TAKING ANTIBIOTICS FOR A PREVIOUSLY DIAGNOSED UTI AND THEN HE RECEIVED HIS ORDER FROM HIS SUPPLIER AND "AT FIRST HE DID NOT NOTICE BUT THEY HAD ACCIDENTALLY GIVEN HIM A DIFFERENT CATHETER THAN WHAT HE WAS USED TO. HE IS ALWAYS USED TO USING THE HM14 HOWEVER HE WAS SENT THE HM14C IN ERROR BY SUPPLIER. FOR THAT PRIOR UTI HE WAS BEING TREATED FOR WITH ANTIBIOTICS, HE WAS NOT BLAMING HIS REGULAR HM14 SAYING HE WAS RECENTLY TRAVELING AND DURING THE PLANE RIDE COULDN'T CATH AS OFTEN AS HE IS USED TO. HE OFTEN GETS CONSTIPATION AS WELL AND HAS NOT BEEN ABLE TO AFFORD HIS MEDICATION TO HELP THIS." HIS HYGIENE ROUTINE WAS REVIEWED AND HE IS ALWAYS GOOD ABOUT WASHING HIS HANDS, CLEANSING HIS GLANS PRIOR TO INSERTION AND USES THE NO TOUCH SLEEVE AND CAREFUL TO NOT CONTAMINATE CATHETER PRIOR TO USE." HE SAID HE USED ABOUT QTY 5 OR 6 OF THE NEW SHIPMENT HE RECEIV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 22467374 ↗
• MalfunctionFeb 26, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21468387 ↗
• MalfunctionJan 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111823 ↗
• MalfunctionNov 21, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  END USER STATES "HE ESTIMATES 1 OR 2 OUT OF EVERY 100 HE HAS USED" THE BLUE LINE AND THE COUDE TIP ARE VERY SLIGHTLY MISALIGNED "ABOUT 2 DEGREES OFF." NO PART NUMBER OR LOT NUMBERS PROVIDED. NO HARM REPORTED FOR THIS CONCERN. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744761 ↗
• MalfunctionNov 21, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  END USER STATES "HE ESTIMATES 1 OR 2 OUT OF EVERY 100 HE HAS USED" THE BLUE LINE AND THE COUDE TIP ARE VERY SLIGHTLY MISALIGNED "ABOUT 2 DEGREES OFF." NO PART NUMBER OR LOT NUMBERS PROVIDED. NO HARM REPORTED FOR THIS CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744759 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 20571282 ↗
• MalfunctionMar 4, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  CATHETER PACKAGING NOT PEELING APART EASILY, PAPER "STICKS AND TEARS IN SPOTS". HE SAID IN HIS LAST 2-3 ORDERS ABOUT 70% OF THE CATHETERS' (NOT EVERY CATHETER AFFECTED IN EACH BOX) PACKAGING IS NOT PEELING APART EASILY IN 2 EVEN PIECES AS HE WAS USED TO. HE SAID IT HAS BEEN STICKING IN SPOTS AND TEARING THE PAPER UNEVENLY. HE SAID VISUALLY NO DEFECTS/ NO DIFFERENCES WITH THE PACKAGING HE CAN TELL PRIOR TO PEELING IT OPEN. HE SAID THE CATHETER WORKS JUST FINE AND IT IS NOT AFFECTED. NO HARM REPORTED JUST THAT IT IS A NUISANCE WITH THE PACKAGING. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825135 ↗
• MalfunctionMar 4, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  CATHETER PACKAGING NOT PEELING APART EASILY, PAPER "STICKS AND TEARS IN SPOTS". HE SAID IN HIS LAST 2-3 ORDERS ABOUT 70% OF THE CATHETERS' (NOT EVERY CATHETER AFFECTED IN EACH BOX) PACKAGING IS NOT PEELING APART EASILY IN 2 EVEN PIECES AS HE WAS USED TO. HE SAID IT HAS BEEN STICKING IN SPOTS AND TEARING THE PAPER UNEVENLY. HE SAID VISUALLY NO DEFECTS/ NO DIFFERENCES WITH THE PACKAGING HE CAN TELL PRIOR TO PEELING IT OPEN. HE SAID THE CATHETER WORKS JUST FINE AND IT IS NOT AFFECTED. NO HARM REPORTED JUST THAT IT IS A NUISANCE WITH THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825134 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED, THAT SOME CATHETERS FEEL LIKE THEY DON'T HAVE ENOUGH HYDROPHILIC COATING ON THEM, NOT AS SLIPPERY AS OTHERS AND THE ONES THAT DON'T HAVE ENOUGH HE SAID THEY "GET STUCK" AS HE IS TRYING TO INSERT THEM ALL ALONG HIS URETHRA AND ALSO FEELS THIS DURING REMOVAL. THEY JUST "DON'T SLIDE IN AS WELL" AS THEY USED TO. HE SAID HE THINKS IT COULD BE SOME WITH NOT ENOUGH COATING ALONG THEM. HE SAID WHEN THEY FEEL "LIKE THEY GET STUCK" IN URETHRA HAS TO USE "EXTRA FORCE" AND HE WILL SEE JUST A TRACE OF BLOOD WHEN THE CATHETER IS REMOVED, BLEEDING STOPS QUICKLY. HE HAS NOTED HOWEVER IN THE LAST 5 MONTHS HE HAS GOTTEN 2 UTIS ABOUT A MONTH APART EACH ONE WITH SYMPTOMS RESOLVING AFTER TREATMENT. HIS SYMPTOMS ARE MALODOROUS URINE, IRRITATION IN URETHRA/BLADDER AND COLOR OF URINE IS DARK. HE SAID EACH TIME HE GOT HIS URINE TESTED AT LAB AND ANTIBIOTICS (NAMES UNKNOWN) WERE PRESCRIBED EACH TIME AND HIS SYMPTOMS RESOLVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17878397 ↗
• MalfunctionOct 4, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  CONSUMER STATES "IN THE PAST HE HAS USED THIS CATHETER HE HAS FOUND SOME WHERE THE GUIDE STRIP DOES NOT MATCH UP EXACTLY IN LINE WITH THE NOTCH ON THE FUNNEL. HE SAID IT IS VERY SLIGHT BUT WANTED TO REPORT IT TO US AS A POTENTIAL DEFECT. HE SAID IT IS "OFF BY ABOUT 10 DEGREES." IT DOES NOT HAPPEN OFTEN, HAS OCCURRED SPORADICALLY IN THE YEAR OR SO HE HAS BEEN USING THESE AND HE SAID WHEN HE NOTICES THIS HE SAID HE JUST MONITORS THE GUIDE STRIPE WHICH IS CORRECTLY PLACED TO DELINEATE THE COUDE TIP. HE SAID HE HAS NO HARM FROM USING THESE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868871 ↗
• MalfunctionSep 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN CONSUMER BURST THE STERILE WATER PACKET HE SAID MAYBE ON 2 OR 3 CATHETERS HE HAS EVER USED IT IMMEDIATELY STARTED TO "LEAK OUT AT THE BOTTOM", NEAR THE TIP OF THE CATHETER LIKE THERE WAS AN ABNORMALITY/ PROBLEM WITH THE THE SEAL OF THE PRODUCT NEAR THE TIP. HE DID NOT USE THEM AS HE WAS CONCERNED BY THIS FOR STERILITY INTEGRITY AND DISCARDED THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839413 ↗
• MalfunctionJul 6, 2023Structural Problem; Structural Problem

  END USER REPORTS THE CATHETER STUCK IN THE PACKAGE "LIKE IT HAD BEEN AROUND TO MUCH HEAT" AND WAS IMPOSSIBLE OR DIFFICULT TO REMOVE. MAY OR MAY NOT HAVE USED SOME FROM THE MU FOR INTERMITTENT URINARY SELF-CATHETERIZATION. EU NORMALLY CATHETERIZES EVERY 3-4 HOURS BUT BECAUSE OF THE ISSUE HE SOMETIMES PROLONGED THE TIME FRAME TO 6-7 HOURS BECAUSE HE WAS CONCERNED HE WOULD RUN OUT OF CATHETERS." HE FURTHER STATES HE USED SOME CATHETERS "FOR INTERMITTENT URINARY SELF-CATHETERIZATION, HE DOES NOT KNOW WHICH MUS HE USED THE CATHETERS FROM BUT THEY HAD BITS OF THE PLASTIC PACKAGE ADHERING TO THE CATHETER. THE BITS OF PLASTIC WERE SHARP LIKE A RAZOR BLADE AND DREW ONE OR TWO DROPS OF BLOOD FROM THE URINARY TRACT WHICH RESOLVED THE NEXT DAY WITHOUT INTERVENTION."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17270975 ↗
• InjuryApr 27, 2023Device Handling Problem; Device Handling Problem

  END USER MENTIONED HE HAS GOTTEN "2 UTIS IN (B)(6) 2022 AND (B)(6) 2023 SINCE CATHING AND HAS BEEN USING THIS CATHETER WHEN HE GOT THEM. HE SAID HE JUST THINKS IT IS FROM THE CATHING, PLACING A FOREIGN OBJECT IN HIS BLADDER, NOT BLAMING THE CATHETER. HE SAID THE UTI HE HAD IN (B)(6) 2022 HE NOTED WHITE MILKY SUBSTANCE AT END OF CATHETER DRAINAGE AND THIS OCCURRED FOR 4 DAYS BEFORE TELLING HIS MD. HIS MD HAD HIM DO A URINE TEST WHICH SHOWED THEY WERE WHITE BLOOD CELLS HE WAS TOLD AND HE WAS PRESCRIBED CIPROFLOXACIN FOR A WEEK. HE SAID THE SAME THING OCCURED FOR 2 DAYS IN (B)(6) 2023 BUT HIS MD JUST REFILLED HIS CIPRO THIS TIME WITHOUT MAKING HIM DO A URINE TEST. THE CIPROFLOXACIN CLEARED UP HIS SYMPTOM QUICKLY BOTH TIMES. HE DOES WASH HIS HANDS PRIOR TO CATHING WELL WITH ANTIBACTERIAL SOAP. HE ALSO WIPES DOWN A LUBE PACKET WITH ALCOHOL AS WELL AS THE SCISSORS BLADES HE USES TO OPEN IT WITH. CONSUMER STATES HE TYPICALLY DOES NOT BURST THE WATER PACKET AND JUST LEAVES THE WATER PACKET INSIDE THE PACKAGING. HE PREPS SINK AREA BY SPRAYING IT WITH LYSOL, DRYING IT WITH PAPER TOWEL. HE THEN PLACES A NEW PAPER TOWEL AND SQUEEZES THE LUBE PACKET ONTO PAPER TOWEL SO HE CAN COATS CATHETER WIT

  Patient problems: Urinary Tract Infection

  MAUDE report 16823077 ↗
• InjuryApr 27, 2023Device Handling Problem; Device Handling Problem

  END USER MENTIONED HE HAS GOTTEN "2 UTIS IN (B)(6) 2022 AND (B)(6) 2023 SINCE CATHING AND HAS BEEN USING THIS CATHETER WHEN HE GOT THEM. HE SAID HE JUST THINKS IT IS FROM THE CATHING, PLACING A FOREIGN OBJECT IN HIS BLADDER, NOT BLAMING THE CATHETER. HE SAID THE UTI HE HAD IN AUGUST HE NOTED WHITE MILKY SUBSTANCE AT END OF CATHETER DRAINAGE AND THIS OCCURRED FOR 4 DAYS BEFORE TELLING HIS MD. HIS MD HAD HIM DO A URINE TEST WHICH SHOWED THEY WERE WHITE BLOOD CELLS HE WAS TOLD AND HE WAS PRESCRIBED CIPROFLOXACIN FOR A WEEK. HE SAID THE SAME THING OCCURED FOR 2 DAYS IN (B)(6) 2023 BUT HIS MD JUST REFILLED HIS CIPRO THIS TIME WITHOUT MAKING HIM DO A URINE TEST. THE CIPROFLOXACIN CLEARED UP HIS SYMPTOM QUICKLY BOTH TIMES. HE DOES WASH HIS HANDS PRIOR TO CATHING WELL WITH ANTIBACTERIAL SOAP. HE ALSO WIPES DOWN A LUBE PACKET WITH ALCOHOL AS WELL AS THE SCISSORS BLADES HE USES TO OPEN IT WITH. CONSUMER STATES HE TYPICALLY DOES NOT BURST THE WATER PACKET AND JUST LEAVES THE WATER PACKET INSIDE THE PACKAGING. HE PREPS SINK AREA BY SPRAYING IT WITH LYSOL, DRYING IT WITH PAPER TOWEL. HE THEN PLACES A NEW PAPER TOWEL AND SQUEEZES THE LUBE PACKET ONTO PAPER TOWEL SO HE CAN COATS CATHETER WITH IT.

  Patient problems: Urinary Tract Infection

  MAUDE report 16823074 ↗
• MalfunctionDec 15, 2022Sharp Edges; Sharp Edges

  END USER REPORTS THE CATHETERS "ARE ALREADY STICKING IN THE PACKAGING NEARLY "50% BONDED TO PACKAGE" EVEN BEFORE ACTIVATION HE DOES NOT USE THEM. HE SAID EVEN AFTER ACTIVATION THESE WILL "RIP PAPER FIBER" WHEN HE GOES TO REMOVE THEM. HIS CONCERN IS ALSO THAT THESE CATHETERS HAVE A "SHARP EDGE" ONCE UNGLUED TO PACKAGING ON THAT AREA THAT WAS STUCK ALONG WITH PAPER FIBERS. HE ALSO NOTES THAT THE AREA NEAR THE TIP IS UNCOMFORTABLE AS THE COATING AFTER ACTIVATION CAN LOOK LIKE "LUMPS, CHUNKS, GRAINS OF SUGAR" WHICH MAKES THE TIP UNCOMFORTABLE IF USED. HE SAID HE HAS USED 10 X MAGNIFICATION AND HE SAID HE THINKS IT'S BECAUSE THE HYDROPHILIC COATING IS INITIALLY PLACED UNEVENLY. HE SAID HE KNOWS IT'S THE COATING AS HE HAS LET THEM DRY JUST TO OBSERVE THEM AND DOES NOT USE THEM AND HE SAID THESE LUMPS DISAPPEAR AND DRY OUT. LAST WEEK HE DID END UP USING ONE THAT WAS STUCK TO PACKAGING AND HE SAID HE "REGRETS IT". HE STARTED TO FEEL SHARP PAIN WITH INSERTION AS THE COATING CREATED A SHARP EDGE TO THE CATHETER. PAIN WENT AWAY AFTER USE, NO INTERVENTIONS NEEDED." A SEPARATE CASE HAS BEEN CREATED FOR THE "RIP PAPER FIBER".

  Patient problems: Pain

  MAUDE report 15986289 ↗
• MalfunctionDec 15, 2022Sharp Edges; Sharp Edges

  END USER REPORTS THE CATHETERS "ARE ALREADY STICKING IN THE PACKAGING NEARLY "50% BONDED TO PACKAGE" EVEN BEFORE ACTIVATION HE DOES NOT USE THEM. HE SAID EVEN AFTER ACTIVATION THESE WILL "RIP PAPER FIBER" WHEN HE GOES TO REMOVE THEM. HIS CONCERN IS ALSO THAT THESE CATHETERS HAVE A "SHARP EDGE" ONCE UNGLUED TO PACKAGING ON THAT AREA THAT WAS STUCK ALONG WITH PAPER FIBERS. HE ALSO NOTES THAT THE AREA NEAR THE TIP IS UNCOMFORTABLE AS THE COATING AFTER ACTIVATION CAN LOOK LIKE "LUMPS, CHUNKS, GRAINS OF SUGAR" WHICH MAKES THE TIP UNCOMFORTABLE IF USED. HE SAID HE HAS USED 10 X MAGNIFICATION AND HE SAID HE THINKS IT'S BECAUSE THE HYDROPHILIC COATING IS INITIALLY PLACED UNEVENLY. HE SAID HE KNOWS IT'S THE COATING AS HE HAS LET THEM DRY JUST TO OBSERVE THEM AND DOES NOT USE THEM AND HE SAID THESE LUMPS DISAPPEAR AND DRY OUT. LAST WEEK HE DID END UP USING ONE THAT WAS STUCK TO PACKAGING AND HE SAID HE "REGRETS IT". HE STARTED TO FEEL SHARP PAIN WITH INSERTION AS THE COATING CREATED A SHARP EDGE TO THE CATHETER. PAIN WENT AWAY AFTER USE, NO INTERVENTIONS NEEDED." A SEPARATE CASE HAS BEEN CREATED FOR THE "RIP PAPER FIBER".

  Patient problems: Pain

  MAUDE report 15986287 ↗
• MalfunctionDec 15, 2022Sharp Edges; Sharp Edges

  END USER REPORTS THE CATHETERS "ARE ALREADY STICKING IN THE PACKAGING NEARLY "50% BONDED TO PACKAGE" EVEN BEFORE ACTIVATION HE DOES NOT USE THEM. HE SAID EVEN AFTER ACTIVATION THESE WILL "RIP PAPER FIBER" WHEN HE GOES TO REMOVE THEM. HIS CONCERN IS ALSO THAT THESE CATHETERS HAVE A "SHARP EDGE" ONCE UNGLUED TO PACKAGING ON THAT AREA THAT WAS STUCK ALONG WITH PAPER FIBERS. HE ALSO NOTES THAT THE AREA NEAR THE TIP IS UNCOMFORTABLE AS THE COATING AFTER ACTIVATION CAN LOOK LIKE "LUMPS, CHUNKS, GRAINS OF SUGAR" WHICH MAKES THE TIP UNCOMFORTABLE IF USED. HE SAID HE HAS USED 10 X MAGNIFICATION AND HE SAID HE THINKS IT'S BECAUSE THE HYDROPHILIC COATING IS INITIALLY PLACED UNEVENLY. HE SAID HE KNOWS IT'S THE COATING AS HE HAS LET THEM DRY JUST TO OBSERVE THEM AND DOES NOT USE THEM AND HE SAID THESE LUMPS DISAPPEAR AND DRY OUT. LAST WEEK HE DID END UP USING ONE THAT WAS STUCK TO PACKAGING AND HE SAID HE "REGRETS IT". HE STARTED TO FEEL SHARP PAIN WITH INSERTION AS THE COATING CREATED A SHARP EDGE TO THE CATHETER. PAIN WENT AWAY AFTER USE, NO INTERVENTIONS NEEDED." A SEPARATE CASE HAS BEEN CREATED FOR THE "RIP PAPER FIBER".

  Patient problems: Pain

  MAUDE report 15986284 ↗
• MalfunctionDec 15, 2022Sharp Edges; Sharp Edges

  END USER REPORTS THE CATHETERS "ARE ALREADY STICKING IN THE PACKAGING NEARLY "50% BONDED TO PACKAGE" EVEN BEFORE ACTIVATION HE DOES NOT USE THEM. HE SAID EVEN AFTER ACTIVATION THESE WILL "RIP PAPER FIBER" WHEN HE GOES TO REMOVE THEM. HIS CONCERN IS ALSO THAT THESE CATHETERS HAVE A "SHARP EDGE" ONCE UNGLUED TO PACKAGING ON THAT AREA THAT WAS STUCK ALONG WITH PAPER FIBERS. HE ALSO NOTES THAT THE AREA NEAR THE TIP IS UNCOMFORTABLE AS THE COATING AFTER ACTIVATION CAN LOOK LIKE "LUMPS, CHUNKS, GRAINS OF SUGAR" WHICH MAKES THE TIP UNCOMFORTABLE IF USED. HE SAID HE HAS USED 10 X MAGNIFICATION AND HE SAID HE THINKS IT'S BECAUSE THE HYDROPHILIC COATING IS INITIALLY PLACED UNEVENLY. HE SAID HE KNOWS IT'S THE COATING AS HE HAS LET THEM DRY JUST TO OBSERVE THEM AND DOES NOT USE THEM AND HE SAID THESE LUMPS DISAPPEAR AND DRY OUT. LAST WEEK HE DID END UP USING ONE THAT WAS STUCK TO PACKAGING AND HE SAID HE "REGRETS IT". HE STARTED TO FEEL SHARP PAIN WITH INSERTION AS THE COATING CREATED A SHARP EDGE TO THE CATHETER. PAIN WENT AWAY AFTER USE, NO INTERVENTIONS NEEDED." A SEPARATE CASE HAS BEEN CREATED FOR THE "RIP PAPER FIBER".

  Patient problems: Pain

  MAUDE report 15986283 ↗