BD Intermittent RTU14CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06948796203998), received between Dec 11, 2023 and Jul 2, 2025 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS NOT ABLE TO VOID URINE, ONLY BLOOD COMES OUT. THE PATIENT HAS A UTI. IT IS UNCLEAR IF THE UTI IS A RESULT OF THE PRODUCT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22384636 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT GET RID OF URINARY TRACT INFECTION WITH MEDICINES FROM DOCTOR PRESCRIBED. PATIENT CHANGED TO A DIFFERENT PRODUCT TO SEE IF THE URINARY TRACT INFECTION GOES AWAY. THE PATIENT HAD USED THIS PRODUCT BEFORE. PER ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER FOLLOW UP ON 09APR2024, IT WAS REPORTED THAT THE CUSTOMER WAS ABLE TO SWITCH CATHETERS BUT WAS STILL EXPERIENCING URINARY TRACT INFECTION. THE PATIENT DID SEEK MEDICAL ATTENTION AND WAS PRESCRIBED MEDICATION. NO CONFIRMATION THAT THE CATHETERS ARE CAUSING THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 18999330 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTION AND WENT TO THE DOCTOR. THE DOCTOR PUT INTERMITTENT CATHETERS IN PATIENT DUE TO INFECTION. THEY WERE UNSURE THE ROOT CAUSE OF INFECTION. IT WAS UNKNOWN IF THE DEVICE CAUSED THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18301579 ↗

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, Classified
  BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F