BD Intermittent RTU16CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 06948796204001), received between Apr 27, 2022 and Apr 16, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PATIENT STATED HE HAD TO THROW A LOT OF THE CATHETERS AWAY DUE TO PARTICLES IN THE LUBE. PT SAID THAT HE GOT A LOT OF INFECTIONS DUE TO THIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER FOLLOW UP, VIA PHONE ON 17APR2025, IT WAS REPORTED, SWITCHED OVER TO THE MAGIC3 CATHETER AND IS ALL GOOD NOW.

  Patient problems: Unspecified Infection

  MAUDE report 21849353 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT GOT URINARY TRACT INFECTION TWICE WITH THIS SET OF CATHETERS AND THEY STATED THEIR DOCTOR OFFICE ADVISED THAT THEY SHOULD CALL LIBERATOR MEDICAL SUPPLY REPRESENTATIVE TO REPORT. THEY DID NOT WANT TO REPLACE THEM AND WILL CONTINUE USE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 20368472 ↗
• InjurySep 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLOOD CLOTS AFTER SCRATCHING THEIR URETHRA WITH THE INTERMITTENT CATHETERS. THE PATIENT HAD INCREASED 6 TIMES A DAY. THE PATIENT HAD A DOCTOR'S OFFICE VISIT ON (B)(6) REGARDING THIS.

  Patient problems: Hematuria

  MAUDE report 20235855 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT USED ONE OF THESE BEVER MALE COUDE HYDROPHILIC CATHETER LAST WEEK AND JUST HOURS AFTER USING THE CATHETER THEY FELT A BURNING SENSATION, AND THEN WHEN THE CUSTOMER WENT TO VOID THEM URINE WAS CLOUDY. IT WAS STATED THIS WEEK THE CUSTOMER WENT TO THEM UROLOGIST'S OFFICE AND THEY TESTED PATIENT URINE AND THEY CURRENTLY HAD A URINARY TRACT INFECTION. THE PATIENT STATED THEY PRESCRIBED MEDICATION TO TREAT THE URINARY TRACT INFECTION. IT WAS NOT CLEAR WHETHER THE PATIENT HAD SAMPLES TO RETURN FOR EVALUATION.

  Patient problems: Burning Sensation; Urinary Tract Infection

  MAUDE report 20049940 ↗
• InjuryJul 15, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INSERT 16FR BEVER COUDE HYDROPHILIC CATHETERS ANYMORE AND HAD BEEN GETTING URINARY TRACT INFECTIONS WHILE ATTEMPTING TO USE THE 16FR CATHETERS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 15028797 ↗
• InjuryMay 4, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE UNCOMFORTABLE. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON (B)(6) 2022, IT WAS STATED THAT THE INTERMITTENT CATHETERS WERE WEAK AND THE PATIENT WAS EXPERIENCING URINARY TRACT INFECTION. PATIENT NEVER HAD ISSUES WITH PRIMARY ITEM MAGIC 3 GO INTERMITTENT CATHETER. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Discomfort; Urinary Tract Infection

  MAUDE report 14274814 ↗
• InjuryApr 27, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE BEVER COUDE HYDROPHILIC INTERMITTENT CATHETERS THAT THE PATIENT RECEIVED WERE VERY DIFFICULT TO GET PAST THE PATIENT'S PROSTATE AND DIFFICULT TO CONTROL. THE PATIENT COULD NOT GRAB THE TUBE, SO THEY COULD NOT NAVIGATE THE CATHETER AT ALL. IT WAS STATED THAT THE PATIENT SPENT THE NIGHT IN THE EMERGENCY ROOM WITH A URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 14220676 ↗

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