BD Intermittent RTU14FRecalls & reported problems
Hangzhou Bever Medical Devices Co., Ltd. · BD Ready-To-Use Hydrophilic Catheter · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06948796204063), received between May 22, 2025 and Feb 17, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 29, 2025Open, Classified
Labeling error, Incorrect expiration date
Z-1061-2026 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient Device Interaction Problem1
Patient problems
- Urinary Tract Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT THE PT STATED SHE HAD SOME BLEEDING, SHE SAW HER DOCTOR TODAY AND HE WANTS HER TO ONLY CATH. 1 PER DAY. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24373248 ↗InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT SAID SHE GOT 2 UTI'S FROM THE START OF CATHING. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 23764878 ↗InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD URINARY TRACT INFECTION THE DOCTOR TOLD THEM IT COMES WITH CATHING. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 22069855 ↗
Other Catheter, Urethral devices
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- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- Onli 82124Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82144Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.