Bard® Tiemann Model Urological Catheter Coude Tip 010116Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00801741029875), received between May 23, 2017 and Jan 23, 2026 — classified as 6 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS ARE DEFECTIVE. PATIENT STATED SOMETIMES THE CATHETERS ARE BIGGER THAN OTHERS AND CAN SOMETIMES BE TOO BIG TO BE ABLE TO USE. THE CURVE IN THE COUDE CATHETERS IS NOT ALWAYS THE SAME AND CORRECT. PATIENT SAID SOMETIMES THE COUDE TIP IS CURVED TOO MUCH OR NOT ENOUGH. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172775 ↗
• MalfunctionJan 23, 2026Component Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS ARE DEFECTIVE. PATIENT STATED SOMETIMES THE CATHETERS ARE BIGGER THAN OTHERS AND CAN SOMETIMES BE TOO BIG TO BE ABLE TO USE. THE CURVE IN THE COUDE CATHETERS IS NOT ALWAYS THE SAME AND CORRECT. PATIENT SAID SOMETIMES THE COUDE TIP IS CURVED TOO MUCH OR NOT ENOUGH. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172771 ↗
• MalfunctionJan 23, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT SAID HE NOTICES THE PACKAGING IS NOT WATER / ALCOHOL PROOF AND WANTS A TECHNICIAN TO CALL HIM FROM BARD TO GO OVER SOLUTIONS AS HE IS CLAIMING THE CATHETERS ARE NOT STERILE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164317 ↗
• MalfunctionJan 22, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT SAID THE NEW PACKAGING IS EASILY CONTAMINATED AND HE HAS TO DECONTAMINATE EVERY TIME PRIOR TO USE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157205 ↗
• MalfunctionJan 8, 2026Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PATIENT SAID HE THINKS THE PACKAGING HAS CHANGED ON THIS CATHETER; SPECIFICALLY, HE SAID HE THINKS THE PLASTIC BACKING IS NO LONGER THERE, SO IT ISN'T WATERPROOF. PER FOLLOW UP INFORMATION RECEIVED ON 05JAN2026, PT PROVIDED LOT NO. MYAN1753 AND PT SAID THE PACKAGING HAD CHANGED ON THE CATHETERS AND THE PACKAGING IS NOT WATER OR ALCOHOL PROOF. THEY SAID THEY WANTS A TECHNICIAN FROM BARD TO CALL THEM TO GO OVER SOLUTIONS BECAUSE THEY THINK THE CATHETERS ARE NO LONGER STERILE, AND HE MAY ALSO WANT TO SWITCH SUPPLIERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24013721 ↗
• MalfunctionOct 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THEY HAD INTERMITTENT CATHETER IN WAREHOUSE A LOT MORE PRODUCT THAN WAS NEEDED FOR AN UPCOMING PAST TEST. PRODUCT WAS GONE TO BE DESTROYED. THE PRODUCT WAS ORANGE IN COLOR AND SO THEY DECIDED TO TAKE SOME OF THE PRODUCT AND CREATE A PUMPKIN OUT OF THAT. THEY OPENED 100 PACKAGES AND ONE OF THEM CONTAINED DEBRIS IN THE EYELET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353584 ↗
• MalfunctionJul 14, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT STATED THEY HAD BEEN USING RED RUBBER INTERMITTENT CATHETERS, 16FR 010116 FOR SEVERAL YEARS. IT USED TO BE MANUFACTURED IN MEXICO, BUT NOW IT WAS MANUFACTURED IN MALAYSIA. PATIENT WAS NOT HAPPY WITH THE CHANGES SINCE MANUFACTURING LOCATION CHANGED. PATIENT STATED THE NEW CATHETERS HAD A LARGER EYELET WHICH SEEMED TO GET CLOGGED EASIER. IT ALSO SEEMS TO HAD A SHARPER TIP MADE INSERTION MORE DIFFICULT. MEXICO MANUFACTURED LOT: NGGR2423. MALAYSIA MANUFACTURED LOT: NGJW1905. ADVISED BD'S MANUFACTURING PROCEDURES ARE STANDARDIZED ACROSS PLANTS AND ARE BASED UPON THE SPECIFIC PRODUCT BEING MADE. HOWEVER, THE PRODUCTS MAY APPEAR SLIGHTLY DIFFERENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496263 ↗
• MalfunctionJul 14, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PATIENT STATED THEY HAD BEEN USING RED RUBBER INTERMITTENT CATHETERS, 16FR 010116 FOR SEVERAL YEARS. IT USED TO BE MANUFACTURED IN MEXICO, BUT NOW IT WAS MANUFACTURED IN MALAYSIA. PATIENT WAS NOT HAPPY WITH THE CHANGES SINCE MANUFACTURING LOCATION CHANGED. PATIENT STATED THE NEW CATHETERS HAD A LARGER EYELET WHICH SEEMED TO GET CLOGGED EASIER. IT ALSO SEEMS TO HAVE A SHARPER TIP MADE INSERTION MORE DIFFICULT. MEXICO MANUFACTURED LOT: NGGR2423. MALAYSIA MANUFACTURED LOT: NGJW1905. ADVISED BD'S MANUFACTURING PROCEDURES ARE STANDARDIZED ACROSS PLANTS AND ARE BASED UPON THE SPECIFIC PRODUCT BEING MADE. HOWEVER, THE PRODUCTS MAY APPEAR SLIGHTLY DIFFERENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495435 ↗
• MalfunctionApr 14, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HAVING ISSUES WITH THE QUALITY OF THE INTERMITTENT CATHETER, UNABLE TO USE A FEW. THE CUSTOMER STATED HAD HAPPENED IN LAST 3 ORDERS. PER FOLLOW UP VIA PHONE ON 25MAR2025, IT WAS REPORTED THAT THE CATHETERS FROM THAT BATCH WERE NOT MOULDED PROPERLY. HE STATED THAT THEY USED TO BE MADE IN MEXICO BUT THEY ARE NOW MADE IN MALAYSIA. THEY HAD THE ISSUE SINCE THEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832481 ↗
• MalfunctionJan 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE ISSUE STARTED WITH SHIPPING A DIFFERENT CATHETER. THE CATHETER COLOR WAS DIFFERENT AND MADE A LITTLE DIFFERENT. THEY STARTED NOTICING IRRITATION AND SOME BLOOD AT TIMES. THEY NOTICED THE LIGHTER COLORED ONES CAUSED THE PROBLEM AND IT HAD A LITTLE LARGER HOLE. THE HOLE WAS CLOSER TO THE BEND THAN TO THE DARKER COLORED ONES. THE PATIENT USES 5 OR 6 CATHETERS A DAY, SO THEY ARE AWARE OF WHEN THERE ARE CHANGES. THEY NOTICED THAT THE ONES CAUSING THE PROBLEM WERE MADE IN MALAYSIA AND THE OTHER WAS UNITED STATES MADE BUT PACKAGED IN MEXICO. THEY WOULD LIKE TO SPEAK TO SOMEONE ABOUT THIS ISSUE AND HOW BEST TO SOLVE IT. PER CUSTOMER VIA PHONE ON 03JAN2025, IT WAS REPORTED THAT THE EYELET ON THE CATHETERS MANUFACTURED IN MALAYSIA WERE LARGER AND CAUSED A LITTLE IRRITATION. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER FOLLOW UP ON 04JAN2025. CUSTOMER IDENTIFIED LOT NGHZ2011, WHICH WERE MANUFACTURED IN MALAYSIA, AS THE PROBLEMATIC LOT THAT HAD A LARGE EYELET AND CAUSED IRRITATION. CUSTOMER ALSO IDENTIFIED LOT NGHT2414 AS THE PRODUCT THAT WAS PACKAGED IN MEXICO, AND IN COMPARISON, THERE WERE NO ISSUES. CUSTOMER REQUESTED THAT THEY ONLY SENT CATHETERS THAT ARE UNI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Inflammation/ Irritation

  MAUDE report 21092198 ↗
• MalfunctionNov 15, 2024Collapse; Collapse

  IT WAS REPORTED THAT BY USING INTERMITTENT CATHETER CUSTOMER EXPERIENCED BLEEDING AND COLLAPSING WHEN PUT INTO URINARY TRACT. IT WAS AN ONGOING ISSUE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE ON 01OCT2024, IT WAS REPORTED THAT THE CATHETERS FROM THE MALAYSIAN FACILITY DID NOT WORK. ALSO STATED THAT THE TIPS COLLAPSED WHICH CAUSED BLEEDING AND DID NOT SEEK MEDICAL ATTENTION. PER SAMPLE FORM RECEIVED ON 25OCT2024, IT WAS REPORTED THAT THE CATHETERS COLLAPSE, FOLD OVER ON INLET HOLE UPON ATTEMPTED INSERTION, IN THE PROCESS IT PINCHES URINARY TRACT WALLS CASED. BLEEDING, PATIENT DID FEEL IT AND IT WAS IMPOSSIBLE TO DRAIN THE BLADDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20693889 ↗
• MalfunctionOct 7, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER HAVING ISSUES WITH THE INTERMITTENT COUDE CATHETER WERE DIFFERENT SIZES IN DIAMETER AND THE BIGGER ONE WERE THICKER IN SIZE AND THEY COULD FELT THE DIFFERENCE. THE REPRESENTATIVE ADVISED CUSTOMER NOT TO USE ANYTHING THAT HURT THEM AND COULD SWAPPED THEM OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385104 ↗
• MalfunctionSep 3, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BARDA COUDE INTERMITTENT CATHETER SIZE WAS NOT CONSISTENT AND THE LOCATION OF THE HOLE WAS NOT CONSISTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126141 ↗
• MalfunctionSep 3, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE BARDA COUDE INTERMITTENT CATHETER SIZE WAS NOT CONSISTENT, AND THE LOCATION OF THE HOLE WAS NOT CONSISTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126019 ↗
• InjuryAug 6, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE CUSTOMER WOULD NORMALLY RECEIVE A USA PRODUCT PACKAGED IN MEXICO (LOT#NGHX0445), BUT THEY RECEIVED A PRODUCT PACKAGED IN MALAYSIA (LOT#NGJQ1481) THAT HAD BEEN DEFECTIVE. THE PRODUCT PACKAGED IN MEXICO (LOT#NGHX0445) WAS USED OVER A YEAR AND IS NOW DARK BROWN IN COLOR WHILE THE ONE FROM MALAYSIA (LOT#NGJQ1481) WAS BRIGHT ORANGE. WHEN THE CATHETER WAS INSERTED, THE CATHETER FOLDS AND BUNCHES UP AND THE ISSUE WAS ONGOING, WHICH RESULTED IN THE PATIENT EXPERIENCING URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER ADDITIONAL INFORMATION RECEIVED 29JUL2024, IT WAS REPORTED THAT THE INCIDENT OF THE CATHETER FOLDING UP ON ITSELF DURING INSERTION HAPPENED WEEKS AGO. PATIENT WAS ADDRESSED WITH URINARY TRACT INFECTION BY DOCTOR AND PRESCRIBED ANTI BIOTICS AFTER THE URINALYSIS CONCLUDED PATIENT HAD URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 19920921 ↗
• MalfunctionJul 11, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED 3 BOXED OF COUDE CATHETER EARLIER THAT MONTH. WHILE USING THE THIRD BOX, THE CATHETERS WERE DIFFICULT TO INSERT. THREE DIFFERENT NURSES ATTEMPTED INSERTION WITH NO SUCCESS. IT WAS NOTED THAT THE THIRD BOX WAS UNLIKE THE OTHER TWO, WAS MADE IN MALAYSIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719155 ↗
• MalfunctionJun 3, 2024Inadequacy of Device Shape and/or Size; Material Twisted/Bent; Inadequacy of Device Shape and/or Size; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT ONLY HAD THE USE OF ONE HAND, AND THEY CAN INSERT THE INTERMITTENT CATHETER HALF OF THE WAY IN, BUT THEN THE CATHETER BENDS. THE PATIENT STATED THAT THE CAREGIVER COULD GET IT IN WITH NO PROBLEMS, BUT THE PATIENT COULD NOT. REPRESENTATIVES SENT SAMPLES TO THE PATIENT, BUT THEY WERE NOT WORKING EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446728 ↗
• MalfunctionMay 6, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER USED TO WORK WITH THE 16FR INTERMITTENT CATHETERS AND DID NOT HAD ISSUES, EXCEPT FOR NOW THE BOXES CUSTOMER RECEIVED HAD A POST IT NOTED AT THE END OF THE BOXES LIKE THEY HAD BEEN REMARKED. ALSO NOTICED THE HOLE WAS MUCH SMALLER THAN THE ONES THAT THEY USED TO GET, SAME PRODUCT BUT THEY LOOK DIFFERENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249481 ↗
• MalfunctionApr 17, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER USED A TIEMANN MODEL COUDE TIP INTERMITTENT CATHETER AND EXPERIENCED A DIFFERENT FEEL, LOOKED FOR THE GUIDE ON THE FUNNEL AND STARTED TO PULL CATHETER OUT AND NOTICED THAT THE GUIDE WAS NOT LINED UP CORRECTLY AS IT IS USED TO MAKE SURE IT WAS GOING IN CORRECTLY. NO INJURIES OR PROBLEMS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124338 ↗
• MalfunctionJan 12, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT HAS BEEN USING INTERMITTENT CATHETER FOR SEVERAL YEARS, OVER THE LAST TWO WEEKS CALLER AND PATIENT HAD BEEN EXPERIENCING A PROBLEM DURING INSERTION. CALLER STATED DURING INSERTION CATHETER GOT TO A CERTAIN POINT AND THEY WERE MET WITH RESISTANCE. REPRESENTATIVE CONFIRMED DURING INSERTION THE HOOK WAS FACING UPWARD. ADVISED CALLER TO CONTACT PATIENT UROLOGIST TO SCHEDULE AN APPOINTMENT. ADVISED NOT TO ATTEMPT TO PUSH AGAINST THE CATHETER RESISTANCE AS IT COULD CAUSE URETHRAL IRRITATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503028 ↗
• MalfunctionDec 8, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER GOT 3 BOXES OF 12 INTERMITTENT CATHETERS THAT WERE DEFECTIVE ALL THE SAME LOT. CUSTOMER STATED THAT THE END OF THEM WAS CURL OVER AND WERE VERY HARD. CUSTOMER ALSO MENTIONED THAT UP AT THE TOP THEY WERE SHORTER IN THE PACKAGING, 2 INCH SHORTER THAN USUAL. UP AT THE TOP OF THE CATHETER, THE OUTLET PART THERE WERE A LARGE BUMP ON IT. SO, INSERTION WOULD BE DIFFICULT BECAUSE OF THE HARD CURL END. CUSTOMER REQUEST REPLACEMENT FOR THE DEFECTIVE PRODUCT. PER FOLLOW UP VIA PONE 08JUN2023, CUSTOMER STATED THAT THEY DID NOT USE THE CATHETERS, THEY SAW THE DEFECT BEFORE USE AND WANTED TO INFORM THE COMPANY OF THE AFFECTED LOTS. PER NOTIFICATION FROM INVESTIGATOR ON 31JUL2023, DURING SAMPLE EVALUATION IT WAS FOUND THAT THE SCRATCH FOUND ON THE SHAFT CLOSE TO THE FUNNEL OF CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 20JUN2023, IT WAS REPORTED THAT CUSTOMER OPENED ONE BOX AND SAW A DEFECTIVE CATHETER, CHECKED THE OTHERS IN THE BOX, THEY WERE ALL THE SAME, SO HE THREW THAT BOX AWAY. STATED THAT THE NEXT BOX WAS FINE AND THEN THEY GOT ANOTHER BOX OF DEFECTIVE CATHETERS AND STATED THAT THESE WERE SHORTER THAN THEY SHOULD BE. THE TIPS WERE CURLED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290335 ↗
• MalfunctionSep 15, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER WAS CURRENTLY USING CATHETER 010116, THREE SAMPLES PROVIDED BY UROLOGIST. DURING INSERTION THE PATIENT EXPERIENCED PAIN WHEN PASSING THE PROSTATE. THEY WERE ADVISED BY UROLOGIST TO SOAK CATHETERS IN DISH DETERGENT, RINSE, AIR DRY AND REUSE. PATIENT WAS INQUIRING WHAT CAME IN KIT 4A7044. REPRESENTATIVE ADVISED PATIENT KIT 4A7044 WAS A 14FR, NOT THE 16FR THE PATIENT WAS CURRENTLY USING. SUGGESTED TALKING WITH UROLOGIST REGARDING CATHETER SIZE CHANGE. ALSO ADVISED CATHETER 010116 WAS SINGLE USE AND THEY DID NOT RECOMMEND CLEANING AND REUSING THEM. INFORMED PATIENT TOUCHLESS PLUS INTERMITTENT CATHETER SYSTEM (4A7044) CONTAINED A LUBRICATED RUBBER CATHETER, GLOVES, POVIDONE IODINE SWABS TO CLEAN THEN ANATOMY, A COLLECTION BAG AND AN UNDER PAD. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 17754608 ↗
• MalfunctionAug 22, 2023Fracture; Scratched Material; Fracture; Scratched Material

  IT WAS REPORTED THAT CUSTOMER GOT 3 BOXES OF 12 INTERMITTENT CATHETERS THAT WERE DEFECTIVE ALL THE SAME LOT. CUSTOMER STATED THAT THE END OF THEM WAS CURL OVER AND WERE VERY HARD. CUSTOMER ALSO MENTIONED THAT UP AT THE TOP THEY WERE SHORTER IN THE PACKAGING, 2 INCH SHORTER THAN USUAL. UP AT THE TOP OF THE CATHETER, THE OUTLET PART THERE WERE A LARGE BUMP ON IT. SO, INSERTION WOULD BE DIFFICULT BECAUSE OF THE HARD CURL END. CUSTOMER REQUEST REPLACEMENT FOR THE DEFECTIVE PRODUCT. PER FOLLOW UP VIA PONE 08JUN2023, CUSTOMER STATED THAT THEY DID NOT USE THE CATHETERS, THEY SAW THE DEFECT BEFORE USE AND WANTED TO INFORM THE COMPANY OF THE AFFECTED LOTS. PER NOTIFICATION FROM INVESTIGATOR ON 31JUL2023, DURING SAMPLE EVALUATION IT WAS FOUND THAT THE SCRATCH FOUND ON THE SHAFT CLOSE TO THE FUNNEL OF CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 20JUN2023, IT WAS REPORTED THAT CUSTOMER OPENED ONE BOX AND SAW A DEFECTIVE CATHETER, CHECKED THE OTHERS IN THE BOX, THEY WERE ALL THE SAME, SO HE THREW THAT BOX AWAY. STATED THAT THE NEXT BOX WAS FINE AND THEN THEY GOT ANOTHER BOX OF DEFECTIVE CATHETERS AND STATED THAT THESE WERE SHORTER THAN THEY SHOULD BE. THE TIPS WERE CURLED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595435 ↗
• MalfunctionJun 22, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CUSTOMER GOT 3 BOXES OF 12 INTERMITTENT CATHETERS THAT WERE DEFECTIVE ALL THE SAME LOT. CUSTOMER STATED THAT THE END OF THEM WAS CURL OVER AND WERE VERY HARD. CUSTOMER ALSO MENTIONED THAT UP AT THE TOP THEY WERE SHORTER IN THE PACKAGING, 2 INCH SHORTER THAN USUAL. UP AT THE TOP OF THE CATHETER, THE OUTLET PART THERE WERE A LARGE BUMP ON IT. SO, INSERTION WOULD BE DIFFICULT BECAUSE OF THE HARD CURL END. CUSTOMER REQUEST REPLACEMENT FOR THE DEFECTIVE PRODUCT. PER FOLLOW UP VIA PONE 08JUN2023, CUSTOMER STATED THAT THEY DID NOT USE THE CATHETERS, THEY SAW THE DEFECT BEFORE USE AND WANTED TO INFORM THE COMPANY OF THE AFFECTED LOTS. PER NOTIFICATION FROM INVESTIGATOR ON 31JUL2023, DURING SAMPLE EVALUATION IT WAS FOUND THAT THE SCRATCH FOUND ON THE SHAFT CLOSE TO THE FUNNEL OF INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183149 ↗
• MalfunctionJun 20, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CUSTOMER GOT 3 BOXES OF 12 INTERMITTENT CATHETERS THAT WERE DEFECTIVE ALL THE SAME LOT. CUSTOMER STATED THAT THE END OF THEM WAS CURL OVER AND WERE VERY HARD. CUSTOMER ALSO MENTIONED THAT UP AT THE TOP THEY WERE SHORTER IN THE PACKAGING, 2 INCH SHORTER THAN USUAL. UP AT THE TOP OF THE CATHETER, THE OUTLET PART THERE WERE A LARGE BUMP ON IT. SO, INSERTION WOULD BE DIFFICULT BECAUSE OF THE HARD CURL END. CUSTOMER REQUEST REPLACEMENT FOR THE DEFECTIVE PRODUCT. PER FOLLOW UP VIA PONE (B)(6) 2023, CUSTOMER STATED THAT THEY DID NOT USE THE CATHETERS, THEY SAW THE DEFECT BEFORE USE AND WANTED TO INFORM THE COMPANY OF THE AFFECTED LOTS. PER NOTIFICATION FROM INVESTIGATOR ON 31JUL2023, DURING SAMPLE EVALUATION IT WAS FOUND THAT THE SCRATCH FOUND ON THE SHAFT CLOSE TO THE FUNNEL OF INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164811 ↗