BD Intermittent RTU16MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 06948796203974), received between Feb 28, 2022 and Dec 23, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID THEY WERE CAUSED URINARY TRACT INFECTION WHILE USING THE INTERMITTENT CATHETERS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 20999836 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STOPPED USING INTERMITTENT CATHETERS BRIEFLY BECAUSE OF AN INFECTION AND A SURGERY UNRELATED TO UROLOGICAL ISSUES. THEY DID NOT SPECIFY IF CATHETERS OR ANY OTHER UROLOGICAL ISSUES WERE RELATED TO INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 05DEC2024, STATED THAT THE CUSTOMER DID NOT EXPERIENCE INFECTION FROM THE CATHETERS. THE CUSTOMER HAD AN UNRELATED OBSTRUCTION WHICH CAUSED THE INFECTION AND NEED FOR SURGERY. THE CUSTOMER WAS STILL USING THE CATHETERS.

  Patient problems: Unspecified Infection

  MAUDE report 20723963 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE WHOLE WEEK PATIENT HAD AN INFECTION AND WANTED TO BE BACK TO THE ORIGINAL CATHETERS. IT WAS STATED THAT PATIENT WAS HAVING TROUBLE WITH COUDE TIP AND WANTED STRAIGHT TIP CATHETERS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 14017145 ↗
• InjuryFeb 28, 2022Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLEEDING WHEN THEY TRIED TO INSERT THE INTERMITTENT CATHETERS. IT WAS NOTED THAT THE PATIENT WAS NEW TO CATHETERIZING. PER FOLLOW-UP VIA PHONE ON 03FEB2022, IT WAS REPORTED THAT THE PATIENT USING THE CATHETERS WENT WELL BUT THEN THEY STARTED STOPPING UP WITH BLOOD AND CLOTS. PATIENT WENT TO THE EMERGENCY ROOM AND THEY DID A PROCEDURE TO CLEAN OUT THE URETHRA AND PLACED A FOLEY CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13621155 ↗

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