CORDIS 533553Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032012683), received between Dec 6, 2019 and Dec 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THE PHYSICIAN CANNOT CONNECT THE BRAUN HARNBACK INFUSION THERAPY SET TO THE TWO 5.2F 4 100 CM SUPER TORQUE PLUS STRAIGHT JUDKINS LEFT 4 CATHETERS. THE LUER LOCK CONNECTION IS NOT WORKING PROPERLY AND WAS TOO THIN. FOR THIS REASON, THE BRAUN COCK CANNOT BE CONNECTED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCTS WERE ONLY UNPACKED AND NOT USED ON THE PATIENT, AS THE PROBLEM HAD ALREADY BEEN IDENTIFIED BEFORE THE EXAMINATION. THE PRODUCT WAS TREATED PROFESSIONALLY BY THE CUSTOMER. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THERE WAS NO DAMAGE TO THE SUPER TORQUE DIAGNOSTIC CATHETER NOTICED PRIOR TO OPENING THE PACKAGE. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9429516 ↗
• MalfunctionDec 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THE PHYSICIAN CANNOT CONNECT THE BRAUN HARNBACK INFUSION THERAPY SET TO THE TWO 5.2F 4 100 CM SUPER TORQUE PLUS STRAIGHT JUDKINS LEFT 4 CATHETERS. THE LUER LOCK CONNECTION IS NOT WORKING PROPERLY AND WAS TOO THIN. FOR THIS REASON, THE BRAUN COCK CANNOT BE CONNECTED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCTS WERE ONLY UNPACKED AND NOT USED ON THE PATIENT, AS THE PROBLEM HAD ALREADY BEEN IDENTIFIED BEFORE THE EXAMINATION. THE PRODUCT WAS TREATED PROFESSIONALLY BY THE CUSTOMER. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THERE WAS NO DAMAGE TO THE SUPER TORQUE DIAGNOSTIC CATHETER NOTICED PRIOR TO OPENING THE PACKAGE. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9429307 ↗