BD Intermittent RTU14MRecalls & reported problems
Hangzhou Bever Medical Devices Co., Ltd. · BD Ready-To-Use Hydrophilic Catheter · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06948796203967), received between Aug 23, 2024 and Mar 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper Chemical Reaction” (1 report).
1 other recall cover devices cleared under the same FDA submission (K192468); they may or may not involve this specific model.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Improper Chemical Reaction1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Urinary Tract Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT WHEN THE PATIENT USED THE INTERMITTENT CATHETERS IN THE PAST THEY WERE BENDING WHILE INSERTING AND CAUSED BLEEDING. IT WAS ALSO STATED THAT THEY WERE TOO WET. IT WAS UNCLEAR IF THE LOT NUMBER WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593421 ↗InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SAID THERE WERE MULTIPLE URINARY TRACT INFECTIONS WHICH HAD SLOWED THEIR INTERMITTENT CATHETER USAGE. THE CUSTOMER DID NOT SAY THAT THE CATHETER CAUSED THE URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 20056639 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192468. One submission often covers many models, so check the product and lot details in each record.
- Z-1061-2026 · Nov 29, 2025 · Open, ClassifiedBD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Other Catheter, Urethral devices
- Bardex® All-Silicone Foley Catheter 165814C. R. Bard, Inc. · CATHETER, URETHRAL275 reports
- 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
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82124Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister 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.