Protocol Touch Administration Set with Small Catheter and Retention Cuff 390309Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815112020153), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2019Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  THIS SPONTANEOUS INVALID DEVICE REPORT WAS RECEIVED BY BRACCO UK FROM A HEALTH PROFESSIONAL ON 12-JUN-2019 AND SENT TO BRACCO MILAN ON 21-JUN-2019. IT REFERS TO AN 82 YEAR-OLD FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED DIAGNOSTIC PROCEDURE USING PROTOCOL TOUCH ADMINISTRATION SET. HER MEDICAL HISTORY INCLUDED CHANGE IN BOWEL HABIT, FAECAL LEAKAGE, HEART ATTACK AND CARDIAC STENT INSERTION. IT WAS REPORTED THAT, DURING THE PROCEDURE, THE TIP OF THE CTC CATHETER PASSED THROUGH THE WALL OF THE RECTUM, NO APPARENT RESISTANCE WAS FELT BY THE EXPERIENCED RADIOGRAPHER. PATIENT HAD TO HAVE COLOSTOMY. MEDICAL DEVICE SERIAL NUMBER PROVIDED AS (B)(6). INVESTIGATION RESULTS HAVE BEEN PROVIDED BY BRACCO GROUP QUALITY: THE UNIT (S/N (B)(6) ) WAS REPAIRED BY (B)(6) ON 06 SEP 2019. IT WAS FOUND THAT THE REGULATOR WAS BROKEN. ADDITIONAL FOLLOW UP REVEALED THE FOLLOWING: THE REGULATOR WAS WORKING BUT WAS EXTREMELY NOISY. THE PRESSURE VALVE WAS ADDITIONALLY NOT FUNCTIONING. THE UNIT PASSED FINAL CALIBRATION. THE REGULATOR, PRESSURE VALVE (70 MMHG), AND ALSO THE CAP NUT WERE REPLACED. THE UNIT PASSED ALL FINAL QC TESTING AFTER REPAIRS WERE COMPLETED. A SUBSEQUENT INVESTIGATION WAS REQUESTED FROM THE MA

  Patient problems: Bowel Perforation

  MAUDE report 8744408 ↗