Extension Tube 4A4194Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741051562), received between Dec 27, 2018 and Sep 20, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE EXTENSION TUBING CUSTOMER RECEIVED WAS CURLED AND WOULD NOT STAY STRAIGHT. IT DID NOT ALLOW THE URINE TO DRAIN IN THE NIGHT BECAUSE IT WOULD NOT STAY STRAIGHT. CUSTOMER ALSO STATED THEY USED TO RECEIVE THE STRAIGHT EXTENSION TUBING BUT NOW RECEIVED THE CURLED ONE AND IT WAS NOT WORKING FOR THEM. PER CUSTOMER VIA PHONE ON 07SEP2023, IT WAS REPORTED THAT THE PATIENT WAS RECEIVING THEIR MEDICAL SUPPLIES FROM (B)(4). THE CUSTOMER HAD RECEIVED THE EXTENSION TUBE FROM THEM FOR THE LAST NINE YEARS, BUT OVER THE LAST TWO YEARS, THEY HAD RECEIVED THEM CURLED. IT ARRIVED WARPED AND NOT IN A U-SHAPE. NO MATTER HOW MANY TIMES THEY STRAIGHTENS THE TUBE, IT WOULD NOT HOLD SHAPE. THIS CAUSED THEM DRAIN BAG TO BEND AT NIGHT. WHEN IN PUBLIC, THEY HAD SEVERAL OCCURRENCES WITH THE TUBE PROTRUDING NEAR THEIR THIGH AND PELVIC AREA, CAUSED CONSIDERABLY DISCOMFORT. THE CUSTOMER FELT THIS WAS A MANUFACTURING ERROR, AND THEY WOULD REACH OUT TO HIS VENDOR FOR A SUBSTITUTE OR ALTERNATIVE AS NEEDED. THEY WAS MERELY INQUIRING AS TO WHAT BD CURRENTLY HAD IN THEIR INVENTORY. ONCE THIS INFORMATION HAS BEEN ADDED TO THE COMPLAINT, NO ADDITIONAL INFORMATION IS AVAILABLE, AND NO PHYSICAL SAM

  Patient problems: Discomfort

  MAUDE report 17780089 ↗
• MalfunctionNov 7, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PVC EXTENSION TUBING WAS KINKING UP WHEN THE PATIENT WAS SLEEPING AND IT CAUSED THE CATHETER TO COME LOOSE SO IT CAUSED LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745148 ↗
• MalfunctionMar 18, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THESE EXTENSION TUBING WERE NOT STRAIGHT AND CRINKLING UP CAUSED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810636 ↗
• MalfunctionAug 21, 2019Disconnection; Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CONNECTION PIECE ON THE END OF THE TUBING BECAME HOOKED ON THE CATHETER, AND CAUSED THE CATHETER TO DISCONNECT FROM THE TUBING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8916388 ↗
• MalfunctionDec 27, 2018Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED FOR REF# 4A4194 BUT CONTAINED THE BROWN COLORED LATEX TUBING WHICH COINCIDES WITH REF# 6A4194.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8200602 ↗