GENTLECATH GLIDE 421572Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 30768455143598), received between Oct 30, 2023 and Mar 12, 2026 — classified as 2 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (60 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Sharp Edges

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24580763 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE CATHS 6 X DAY. SHE USES GCAFW OUT OF HOME AND GC GLIDE AT HOME. "EARLY LAST YEAR (B)(6) 2025 SHE WAS HAVING URINE LEAKAGE HAVING TO CHANGE PADS FREQUENTLY AS WELL AS WAS GETTING UTIS SHE NEEDED ANTIBIOTIC TREATMENT FOR. SHE SAW A UROLOGIST AS ADVISED BY HER PCP AND WHICH RAN SEVERAL TESTS INCLUDING A URODYNAMICS TEST WHICH SHOWED HER BLADDER IS NOT FULLY EMPTYING. SHE WAS GIVEN ESTRADIOL VAGINAL CREAM AND IN (B)(6) 2025 ADVISED TO START CIC WHICH SHE HAS BEEN DOING SUCCESSFULLY 6 X A DAY. SHE INITIALLY TRIALED MANY OTHER CATHETERS WHEN SHE FIRST STARTED CIC BUT PREFER OUR GC HYDROPHILIC CATHETERS. IN SUMMER 2025 HER UTIS STARTED OCCURRING AGAIN, THIS TIME WHILE SHE WAS CATHING AND BECAME RECURRENT SHE SAID IT WAS "1 AFTER THE OTHER." HER SYMPTOMS AREA ALWAYS BURNING SENSATION, URGENCY AND CLOUDY URINE AND HAS A DISCOMFORT WITH CATHING AT END OF BLADDER DRAINAGE. HER UROLOGIST STARTED HER ON CRANBERRY SUPPLEMENTS AND TREATED HER WITH ANTIBIOTICS EACH TIME. SHE SAID HER URINE CULTURES SHOWED E. COLI AT FIRST BUT THEN CANNOT REMEMBER THE BACTERIAL RESULTS OF THE OTHER URINE CULTURES SHE NEEDED ANTIBIOTIC TREATMENTS FOR AND THINK THEY WERE DIFFERENT FROM E. COLI. S

  Patient problems: Urinary Tract Infection

  MAUDE report 23974780 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE CATHS 6 X DAY. SHE USES GCAFW OUT OF HOME AND GC GLIDE AT HOME. "EARLY LAST YEAR (B)(6) 2025 SHE WAS HAVING URINE LEAKAGE HAVING TO CHANGE PADS FREQUENTLY AS WELL AS WAS GETTING UTIS SHE NEEDED ANTIBIOTIC TREATMENT FOR. SHE SAW A UROLOGIST AS ADVISED BY HER PCP AND WHICH RAN SEVERAL TESTS INCLUDING A URODYNAMICS TEST WHICH SHOWED HER BLADDER IS NOT FULLY EMPTYING. SHE WAS GIVEN ESTRADIOL VAGINAL CREAM AND IN (B)(6) 2025 ADVISED TO START CIC WHICH SHE HAS BEEN DOING SUCCESSFULLY 6 X A DAY. SHE INITIALLY TRIALED MANY OTHER CATHETERS WHEN SHE FIRST STARTED CIC BUT PREFER OUR GC HYDROPHILIC CATHETERS. IN SUMMER 2025 HER UTIS STARTED OCCURRING AGAIN, THIS TIME WHILE SHE WAS CATHING AND BECAME RECURRENT SHE SAID IT WAS "1 AFTER THE OTHER." HER SYMPTOMS AREA ALWAYS BURNING SENSATION, URGENCY AND CLOUDY URINE AND HAS A DISCOMFORT WITH CATHING AT END OF BLADDER DRAINAGE. HER UROLOGIST STARTED HER ON CRANBERRY SUPPLEMENTS AND TREATED HER WITH ANTIBIOTICS EACH TIME. SHE SAID HER URINE CULTURES SHOWED E. COLI AT FIRST BUT THEN CANNOT REMEMBER THE BACTERIAL RESULTS OF THE OTHER URINE CULTURES SHE NEEDED ANTIBIOTIC TREATMENTS FOR AND THINK THEY WERE DIFFERENT FROM E. COLI. S

  Patient problems: Urinary Tract Infection

  MAUDE report 23974779 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123890 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123873 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123750 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123740 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123714 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123701 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123697 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123694 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123693 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123677 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123671 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123660 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123638 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123634 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123629 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123627 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123622 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123617 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123614 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123590 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123577 ↗
• MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER STATED "THAT SHE USED UP 2 BOXES OF THIS PRODUCT AND SAID THEY ALL HAD THE TOPS THAT WERE NOT FULLY SEALED. THE TOP PULL APART TABS WERE NOT SEALED TOGETHER FOR ABOUT THE FIRST 2 INCHES DOWN THE PACKAGING. SHE SAID SHE HOLDS UP THE CATHETER WHEN SHE BURSTS THE WATER PACKET SO THE BOTTOM PART OF THE PACKAGE WAS INTACT ENOUGH TO HOLD THE WATER TO HYDRATE/ PREP THE CATHETER TO USE IT. SHE SAID SHE USED 2 BOXES WORTH BEFORE LETTING HER SUPPLIER KNOW OF THIS CONCERN AND SHE REPORTS NO HARM WITH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123562 ↗