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BD Intermittent BUC14MRecalls & reported problems

Hangzhou Bever Medical Devices Co., Ltd. · BD Intermittent Catheter · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06948796203844), received between Mar 24, 2022 and Apr 14, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Biocompatibility1
  • Patient Device Interaction Problem1

Patient problems

  • Urinary Tract Infection2
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND HAD TO USE MORE PRODUCT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED FOR INFECTION. PER WIFE VIA PHONE ON (B)(6) 2025, IT WAS REPORTED, THEY DID NOT MAKE COMPLAINT AND THAT NOTHING IS WRONG WITH THE CATHETER BUT THAT HE GETS UTI'S ALL THE TIME.

    Patient problems: Urinary Tract Infection

    MAUDE report 21832596 ↗
  • InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT CUSTOMER WAS TREATED FOR URINARY TRACT INFECTION. CUSTOMER INFORMED THIS DUE TO SOMETHING THAT REGULARLY HAPPENS WHEN USING INTERMITTENT CATHETER. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN.

    Patient problems: Urinary Tract Infection

    MAUDE report 21374195 ↗
  • InjuryMar 24, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION FROM INTERMITTENT CATHETER AND HAD TO GO TO THE EMERGENCY ROOM. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 13872640 ↗

Other Catheter, Urethral devices

All Catheter, Urethral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.