SureStep Intermittent Catheter Tray INTP14Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00801741183294), received between Nov 30, 2021 and Jan 9, 2026 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 25, 2026Open, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3117-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD BEEN AFFECTED 6 SEPARATE TIMES AT (B)(6) HOSPITAL. ALL AT THE SAME UNIT. LOT#NGKU3578 . LOT#NGKS3046 . LOT#NGKS2199 . PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2025, IT WAS REPORTED THAT THE CATHETERS WERE OUTSIDE THE STERILE PACKAGING AND SOME OF THEM WERE KINKED. THE ISSUE WAS DETECTED: MULTIPLE OCCASIONS WHERE THE NURSES WERE OPENING KITS TO STRAIGHT CATHETER. WHETHER THE ISSUE AFFECTED PRODUCT FUNCTIONALITY OR USABILITY VERY INCONVENIENT AS FOR ONE PATIENT THEY HAD TO OPEN 5 KITS TILL THEY GOT ONE THAT WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029086 ↗
• MalfunctionJan 9, 2026Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD BEEN AFFECTED 6 SEPARATE TIMES AT (B)(6). ALL AT THE SAME UNIT. LOT#NGKU3578 LOT#NGKS3046 LOT#NGKS2199 PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2025, IT WAS REPORTED THAT THE CATHETERS WERE OUTSIDE THE STERILE PACKAGING AND SOME OF THEM WERE KINKED. THE ISSUE WAS DETECTED: MULTIPLE OCCASIONS WHERE THE NURSES WERE OPENING KITS TO STRAIGHT CATHETER. WHETHER THE ISSUE AFFECTED PRODUCT FUNCTIONALITY OR USABILITY VERY INCONVENIENT AS FOR ONE PATIENT THEY HAD TO OPEN 5 KITS TILL THEY GOT ONE THAT WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029081 ↗
• MalfunctionJan 9, 2026Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD BEEN AFFECTED 6 SEPARATE TIMES AT (B)(6) HOSPITAL. ALL AT THE SAME UNIT. LOT#NGKU3578. LOT#NGKS3046. LOT#NGKS2199. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2025, IT WAS REPORTED THAT THE CATHETERS WERE OUTSIDE THE STERILE PACKAGING AND SOME OF THEM WERE KINKED. THE ISSUE WAS DETECTED: MULTIPLE OCCASIONS WHERE THE NURSES WERE OPENING KITS TO STRAIGHT CATHETER. WHETHER THE ISSUE AFFECTED PRODUCT FUNCTIONALITY OR USABILITY VERY INCONVENIENT AS FOR ONE PATIENT THEY HAD TO OPEN 5 KITS TILL THEY GOT ONE THAT WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029068 ↗
• MalfunctionDec 19, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER WAS ATTEMPTING TO STRAIGHT CATHETER A PATIENT WITH A NURSING STUDENT. THEY HAD GRABBED A 14F STRAIGHT CATH KIT AND USED IT UP TO THE POINT OF INSERTION AND GETTING URINE FLOW, BUT THE URINE FLOW STOPPED IN THE TUBE. IT WAS THEN REALIZED THAT THERE WAS A LITERAL KINK IN THE TUBING NOT ALLOWING THE URINE TO FLOW AND IT WAS UNABLE TO BE STRAIGHTENED OUT. ANOTHER 14F STRAIGHT CATH KIT WAS OBTAINED BY WRITER AND IMMEDIATELY UPON OPENING IT WAS NOTICED THAT THE WHOLE END OF THAT TUBING WAS BENT AT THE END AND WOULD ALSO NOT ALLOW URINE FLOW VERY WELL, SO IT WAS NOT USED. NEXT, WRITER OBTAINED A 16F COUDE STRAIGHT CATH KIT AND NO ISSUES WITH THAT ONE AND WAS ABLE TO THEN STUDENT WAS ABLE TO PERFORM PROCEDURE. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10DEC2025, IT WAS REPORTED BY THE NURSING INSTRUCTOR ON THE FLOOR THAT DAY AND LEFT THE TWO 14F CATHETERS THAT WERE NOT USEABLE OUT OF THE KIT WITH THE 5 MAIN MANAGER. THEY DO NOT KNOW IF THEY STILL HAVE THEM TWO MONTHS LATER. NURSING INSTRUCTOR ALSO DO NOT HAVE THE PATIENT IDENTIFIER WITH THEM ANYMORE; IT WAS THE SAME FEMALE PATIENT. THE ONLY MEDICAL INTERVENTION REQUIRED WAS THAT IT TOOK THRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850857 ↗
• MalfunctionDec 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CATHETER WAS OUTSIDE OF STERILE FIELD WHEN OPENING TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778301 ↗
• MalfunctionDec 10, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAS SEVERAL STRAIGHT CATHETER KITS PRODUCT # INTP14 THAT THE CATHETER WAS LAYING BETWEEN THE FOLDS OF THE OUTER WRAP THUS COMPROMISING THE POSSIBILITY OF CROSS CONTAMINATION WHEN OPENING THE TRAY UP. CUSTOMER HAVE ATTACHED PICTURES. THEY HAVE 2 DIFFERENT LOT NUMBERS NGKU1438 AND NGKV2964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771177 ↗
• MalfunctionDec 10, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAS SEVERAL STRAIGHT CATHETER KITS PRODUCT # INTP14 THAT THE CATHETER WAS LAYING BETWEEN THE FOLDS OF THE OUTER WRAP THUS COMPROMISING THE POSSIBILITY OF CROSS CONTAMINATION WHEN OPENING THE TRAY UP. CUSTOMER HAVE ATTACHED PICTURES. THEY HAVE 2 DIFFERENT LOT NUMBERS NGKU1438 AND NGKV2964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771033 ↗
• MalfunctionNov 5, 2025Incomplete or Missing Packaging; Component Misassembled; Incomplete or Missing Packaging; Component Misassembled

  IT WAS REPORTED THAT THE STRAIGHT CATHETERIZATION KIT WAS FOUND TO BE UNSTERILE UPON REMOVAL FROM PACKAGE. CATHETER TIP WAS PROTRUDING FROM STERILE WRAP, DEEMING IT UNFITS FOR USE. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 16DEC2025, IT WAS REPORTED THAT NO PATIENT IMPACT WAS REPORTED. AFTER IT WAS NOTICED IT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479828 ↗
• InjuryNov 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE STRAIGHT CATHETER KIT WAS FALL APART OF THE CONNECTION POINT BETWEEN THE CATHETER AND THE BAG DURING INSERTION AND POST INSERTION. THIS WAS INTEGRAL TO THEIR URINARY DRAINAGE POLICY AND WAS LIMITED NURSES FROM USING THIS PROTOCOL. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 23452721 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER WAS ATTEMPTING TO STRAIGHT CATHETER A PATIENT WITH A NURSING STUDENT. THEY HAD GRABBED A 14F STRAIGHT CATH KIT AND USED IT UP TO THE POINT OF INSERTION AND GETTING URINE FLOW, BUT THE URINE FLOW STOPPED IN THE TUBE. IT WAS THEN REALIZED THAT THERE WAS A LITERAL KINK IN THE TUBING NOT ALLOWING THE URINE TO FLOW AND IT WAS UNABLE TO BE STRAIGHTENED OUT. ANOTHER 14F STRAIGHT CATH KIT WAS OBTAINED BY WRITER AND IMMEDIATELY UPON OPENING IT WAS NOTICED THAT THE WHOLE END OF THAT TUBING WAS BENT AT THE END AND WOULD ALSO NOT ALLOW URINE FLOW VERY WELL, SO IT WAS NOT USED. NEXT, WRITER OBTAINED A 16F COUDE STRAIGHT CATH KIT AND NO ISSUES WITH THAT ONE AND WAS ABLE TO THEN STUDENT WAS ABLE TO PERFORM PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290605 ↗
• MalfunctionOct 15, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CUSTOMER WAS ATTEMPTING TO STRAIGHT CATHETER A PATIENT WITH A NURSING STUDENT. THEY HAD GRABBED A 14F STRAIGHT CATH KIT AND USED IT UP TO THE POINT OF INSERTION AND GETTING URINE FLOW, BUT THE URINE FLOW STOPPED IN THE TUBE. IT WAS THEN REALIZED THAT THERE WAS A LITERAL KINK IN THE TUBING NOT ALLOWING THE URINE TO FLOW AND IT WAS UNABLE TO BE STRAIGHTENED OUT. ANOTHER 14F STRAIGHT CATH KIT WAS OBTAINED BY WRITER AND IMMEDIATELY UPON OPENING IT WAS NOTICED THAT THE WHOLE END OF THAT TUBING WAS BENT AT THE END AND WOULD ALSO NOT ALLOW URINE FLOW VERY WELL, SO IT WAS NOT USED. NEXT, WRITER OBTAINED A 16F COUDE STRAIGHT CATH KIT AND NO ISSUES WITH THAT ONE AND WAS ABLE TO THEN STUDENT WAS ABLE TO PERFORM PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290300 ↗
• MalfunctionSep 29, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT SURESTEP INTERMITTENT CATHETER TRAY WAS OPENED, AND THE CATHETER WAS OUTSIDE OF THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167314 ↗
• MalfunctionSep 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED BY CUSTOMER THAT THE FIRST PULLED THE STRAIGHT CATHETER TRAY PAPER BACK THE CATHETER WAS EXPOSED AND NOT WITHIN THE STERILE KIT. THE NURSE SAID IT¿S HAPPENED WITH 2 TO 3 KITS LATELY AND STATED THEY HAVE HAD THE SAME ISSUE AT LEAST 7 TIMES WITHIN THE LAST 2 WEEKS. ONE NURSE SAID THE CATHETER TIP FELL OUT AS SOON AS THE PACKAGE WAS PULLED FROM THE PLASTIC SLEEVE. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 23SEPT2025, IT DID OCCUR AGAIN ON THE 17TH IN THE ED WITH A STRAIGHT CATHETER KIT. THEY DISCARDED THE KIT AND PROVIDED THE MATERIAL REF INTP14 AND LOT # NGKU0148.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144130 ↗
• MalfunctionSep 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WE RECENTLY HAD A PACKAGING ISSUE WITH YOUR SURESTEP INTERMITTENT CATHETER TRAY. ONE TUBING WAS BENT AND ANOTHER WAS COMPRESSED ON TWO KITS AND ON ANOTHER KIT THE LUBE WAS OPEN AND EMPTIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137488 ↗
• MalfunctionSep 24, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT WE RECENTLY HAD A PACKAGING ISSUE WITH YOUR SURESTEP INTERMITTENT CATHETER TRAY. ONE TUBING WAS BENT AND ANOTHER WAS COMPRESSED ON TWO KITS AND ON ANOTHER KIT THE LUBE WAS OPEN AND EMPTIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137485 ↗
• MalfunctionSep 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WE RECENTLY HAD A PACKAGING ISSUE WITH YOUR SURESTEP INTERMITTENT CATHETER TRAY. ONE TUBING WAS BENT AND ANOTHER WAS COMPRESSED ON TWO KITS AND ON ANOTHER KIT THE LUBE WAS OPEN AND EMPTIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137483 ↗
• MalfunctionSep 18, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER HAVE NOTICED A WEIRD PACKAGING PATTERN WITH THE NEW INTERMITTENT CATHETER KITS. WHEN OPENING THE KIT, THE CATHETER TIP TENDS TO BE OUTSIDE OF THE WHITE CONTAINER AND VERY CLOSE TO THE CORNER OF THE STERILE DRAPE. THEY JUST WANTED TO POINT THIS OUT BECAUSE IT SEEMS ODD AND MAY RESULT IN CONTAMINATION IF NOT CAREFUL. PER ADDITIONAL INFORMATION RECEIVED ON 03SEP2025, THE CONCERN WAS THE CATHETER TIP WAS VERY CLOSE THE EDGE OF THE STERILE FIELD AND THIS HAS CAUSED SEVERAL KITS TO BE THROWN OUT BECAUSE OF THE STERILITY CONCERN OF THE CATHETER TIP. THAT HAS BEEN DISCOVERED IN DIFFERENT SIZE KITS AND DIFFERENT LOTS. IT WAS NOT THE SAME IN EVERY KIT BEING OPENED SO THEY WERE NOT SURE WHAT WAS GOING ON. THEY SWITCHED TO THESE KITS TO HELP REDUCE CAUTIONS AND THIS CONCERNS US THAT THEY COULD POTENTIALLY SEE AN INCREASE. PER ADDITIONAL INFORMATION RECEIVED ON 05SEP2025, IT WAS REPORTED THAT THE CUSTOMER HAS 6 LOT NUMBERS IMPACTED AND HAVE NOTICED IT WAS NOT EVERY KIT IN EVERY LOT. CONSIDERING IT WAS 2 PAVILION UNITS, PERIOP SPACES & HUP MAIN CDR, THEY WOULD SAY THE IMPACT WAS HOSPITAL WIDE. THEY MENTIONED THE LOT NUMBER AND PRODUCT AS BELOW: 6FR: PEDINTS06 WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084930 ↗
• MalfunctionSep 17, 2025Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT ONE OF INTENSIVE CARE UNIT NURSES COMMUNICATED WHEN THEY FIRST PULLED THE STRAIGHT CATHETER TRAY PAPER BACK THE CATHETER WAS EXPOSED AND NOT WITHIN THE STERILE KIT. THIS NURSE SAYS IT¿S HAPPENED WITH 2-3 KITS LATELY. SPOKE WITH NURSES ON 4A WHO STATED THEY HAVE HAD THE SAME ISSUE AT LEAST 7 TIMES WITHIN THE LAST 2 WEEKS. ONE NURSE SAYS THE CATHETER TIP FELL OUT AS SOON AS THE PACKAGE WAS PULLED FROM THE PLASTIC SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075272 ↗
• MalfunctionSep 16, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER HAVE NOTICED A WEIRD PACKAGING PATTERN WITH THE NEW INTERMITTENT CATHETER KITS. WHEN OPENING THE KIT, THE CATHETER TIP TENDS TO BE OUTSIDE OF THE WHITE CONTAINER AND VERY CLOSE TO THE CORNER OF THE STERILE DRAPE. THEY JUST WANTED TO POINT THIS OUT BECAUSE IT SEEMS ODD AND MAY RESULT IN CONTAMINATION IF NOT CAREFUL. PER ADDITIONAL INFORMATION RECEIVED ON 03SEP2025, THE CONCERN WAS THE CATHETER TIP WAS VERY CLOSE THE EDGE OF THE STERILE FIELD AND THIS HAS CAUSED SEVERAL KITS TO BE THROWN OUT BECAUSE OF THE STERILITY CONCERN OF THE CATHETER TIP. THAT HAS BEEN DISCOVERED IN DIFFERENT SIZE KITS AND DIFFERENT LOTS. IT WAS NOT THE SAME IN EVERY KIT BEING OPENED SO THEY WERE NOT SURE WHAT WAS GOING ON. THEY SWITCHED TO THESE KITS TO HELP REDUCE CAUTIONS AND THIS CONCERNS US THAT THEY COULD POTENTIALLY SEE AN INCREASE. PER ADDITIONAL INFORMATION RECEIVED ON 05SEP2025, IT WAS REPORTED THAT THE CUSTOMER HAS 6 LOT NUMBERS IMPACTED AND HAVE NOTICED IT WAS NOT EVERY KIT IN EVERY LOT. CONSIDERING IT WAS 2 PAVILION UNITS, PERIOP SPACES & HUP MAIN CDR, THEY WOULD SAY THE IMPACT WAS HOSPITAL WIDE. THEY MENTIONED THE LOT NUMBER AND PRODUCT AS BELOW: 6FR: PEDINTS06 WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064978 ↗
• MalfunctionSep 16, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER HAVE NOTICED A WEIRD PACKAGING PATTERN WITH THE NEW INTERMITTENT CATHETER KITS. WHEN OPENING THE KIT, THE CATHETER TIP TENDS TO BE OUTSIDE OF THE WHITE CONTAINER AND VERY CLOSE TO THE CORNER OF THE STERILE DRAPE. THEY JUST WANTED TO POINT THIS OUT BECAUSE IT SEEMS ODD AND MAY RESULT IN CONTAMINATION IF NOT CAREFUL. PER ADDITIONAL INFORMATION RECEIVED ON 03SEP2025, THE CONCERN WAS THE CATHETER TIP WAS VERY CLOSE THE EDGE OF THE STERILE FIELD AND THIS HAS CAUSED SEVERAL KITS TO BE THROWN OUT BECAUSE OF THE STERILITY CONCERN OF THE CATHETER TIP. THAT HAS BEEN DISCOVERED IN DIFFERENT SIZE KITS AND DIFFERENT LOTS. IT WAS NOT THE SAME IN EVERY KIT BEING OPENED SO THEY WERE NOT SURE WHAT WAS GOING ON. THEY SWITCHED TO THESE KITS TO HELP REDUCE CAUTIONS AND THIS CONCERNS US THAT THEY COULD POTENTIALLY SEE AN INCREASE. PER ADDITIONAL INFORMATION RECEIVED ON 05SEP2025, IT WAS REPORTED THAT THE CUSTOMER HAS 6 LOT NUMBERS IMPACTED AND HAVE NOTICED IT WAS NOT EVERY KIT IN EVERY LOT. CONSIDERING IT WAS 2 PAVILION UNITS, PERIOP SPACES & HUP MAIN CDR, THEY WOULD SAY THE IMPACT WAS HOSPITAL WIDE. THEY MENTIONED THE LOT NUMBER AND PRODUCT AS BELOW: 6FR: PEDINTS06 WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064613 ↗
• MalfunctionSep 16, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER HAVE NOTICED A WEIRD PACKAGING PATTERN WITH THE NEW INTERMITTENT CATHETER KITS. WHEN OPENING THE KIT, THE CATHETER TIP TENDS TO BE OUTSIDE OF THE WHITE CONTAINER AND VERY CLOSE TO THE CORNER OF THE STERILE DRAPE. THEY JUST WANTED TO POINT THIS OUT BECAUSE IT SEEMS ODD AND MAY RESULT IN CONTAMINATION IF NOT CAREFUL. PER ADDITIONAL INFORMATION RECEIVED ON 03SEP2025, THE CONCERN WAS THE CATHETER TIP WAS VERY CLOSE THE EDGE OF THE STERILE FIELD AND THIS HAS CAUSED SEVERAL KITS TO BE THROWN OUT BECAUSE OF THE STERILITY CONCERN OF THE CATHETER TIP. THAT HAS BEEN DISCOVERED IN DIFFERENT SIZE KITS AND DIFFERENT LOTS. IT WAS NOT THE SAME IN EVERY KIT BEING OPENED SO THEY WERE NOT SURE WHAT WAS GOING ON. THEY SWITCHED TO THESE KITS TO HELP REDUCE CAUTIONS AND THIS CONCERNS US THAT THEY COULD POTENTIALLY SEE AN INCREASE. PER ADDITIONAL INFORMATION RECEIVED ON 05SEP2025, IT WAS REPORTED THAT THE CUSTOMER HAS 6 LOT NUMBERS IMPACTED AND HAVE NOTICED IT WAS NOT EVERY KIT IN EVERY LOT. CONSIDERING IT WAS 2 PAVILION UNITS, PERIOP SPACES & HUP MAIN CDR, THEY WOULD SAY THE IMPACT WAS HOSPITAL WIDE. THEY MENTIONED THE LOT NUMBER AND PRODUCT AS BELOW: 6FR: PEDINTS06 WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063383 ↗
• MalfunctionSep 16, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER HAVE NOTICED A WEIRD PACKAGING PATTERN WITH THE NEW INTERMITTENT CATHETER KITS. WHEN OPENING THE KIT, THE CATHETER TIP TENDS TO BE OUTSIDE OF THE WHITE CONTAINER AND VERY CLOSE TO THE CORNER OF THE STERILE DRAPE. THEY JUST WANTED TO POINT THIS OUT BECAUSE IT SEEMS ODD AND MAY RESULT IN CONTAMINATION IF NOT CAREFUL. PER ADDITIONAL INFORMATION RECEIVED ON 03SEP2025, THE CONCERN WAS THE CATHETER TIP WAS VERY CLOSE THE EDGE OF THE STERILE FIELD AND THIS HAS CAUSED SEVERAL KITS TO BE THROWN OUT BECAUSE OF THE STERILITY CONCERN OF THE CATHETER TIP. THAT HAS BEEN DISCOVERED IN DIFFERENT SIZE KITS AND DIFFERENT LOTS. IT WAS NOT THE SAME IN EVERY KIT BEING OPENED SO THEY WERE NOT SURE WHAT WAS GOING ON. THEY SWITCHED TO THESE KITS TO HELP REDUCE CAUTIONS AND THIS CONCERNS US THAT THEY COULD POTENTIALLY SEE AN INCREASE. PER ADDITIONAL INFORMATION RECEIVED ON 05SEP2025, IT WAS REPORTED THAT THE CUSTOMER HAS 6 LOT NUMBERS IMPACTED AND HAVE NOTICED IT WAS NOT EVERY KIT IN EVERY LOT. CONSIDERING IT WAS 2 PAVILION UNITS, PERIOP SPACES & HUP MAIN CDR, THEY WOULD SAY THE IMPACT WAS HOSPITAL WIDE. THEY MENTIONED THE LOT NUMBER AND PRODUCT AS BELOW: 6FR: PEDINTS06 WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063333 ↗
• MalfunctionJul 21, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT CUSTOMER HAD DISCOVERED 10 PLUS SURESTEP INTERMITTENT CATHETER TRAYS TO BE NON-STERILE. USER WAS UNABLE TO USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554922 ↗
• MalfunctionJul 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING CATHETERIZATION OF A PATIENT, THE CATHETER FELL APART SO EASILY FROM THE BAG, AND THE CUSTOMER OPENED ANOTHER KIT IT WAS THE SAME THING WITH ADDITION TO THE ACTUAL CATHETER TIP WAS ALL KINKED. CUSTOMER WAS NOT SURE IF THIS WAS COMMON OR IF THEY HAD A BAD BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412709 ↗
• MalfunctionMay 30, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE OPERATION RESEARCH TEAM DISCOVERED A HOLE IN THE FOLEY CATHETER. THE CATHETER IS NOT AVAILABLE FOR REVIEW. PER CUSTOMER FOLLOW UP RECEIVED VIA EMAIL ON (B)(6) 2025 STATED THAT THE PRODUCT WAS PACKAGED WRONG AND NOT USED ON A PATIENT AND BECAUSE THE REGISTERED NURSE REALIZED IT WAS PACKAGED WRONG, AND THE STERILE FIELD WAS BROKEN. CLINICAL OPENED A URINARY CATHETER KIT, AND THE CATHETER WAS NOT IN THE TRAY AS EXPECTED AND THE STERILE FIELD WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113622 ↗