MAUDE Adverse Event Report: COVIDIEN 1616G LTX CATH 5 CC 2-WAY 16FR; CATHETER, UROLOGICAL

Model Number	1616
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported the balloon was unable to deflate and the catheter was unable to be removed.The balloon later deflated on it's own and came out.There was no injury to the patient.There was no medical intervention given to the patient.
Additional Manufacturer Narrative
The device history record could not be retrieved as the returned sample received was not in complete condition where the funnel part is not available.The traceability of the catheter was printed on the funnel.Without the information, dhr will not be available as the lot number is unknown.A sample received was not in actual condition as it was being cut at the shaft area.However further investigation had been conducted.The sample was subjected to inflation test by which 10 ml water had been used as recommended in the specification.It was observed that the sample was able to inflate as per normal practice, however the balloon of the sample was found lifting.When the syringe is removed from the airline, the sample found to be deflated slowly, not as per normal practice even though the catheter was being cut at the shaft area.The sample received was confirmed as partial deflation.Thus, the reported condition was confirmed.The root cause of the balloon lifting is due to 3rd layer & 4th latex layer after balloon was not properly bonded.The pressure from the water inside the balloon will press the lumen of the catheter (weak area), led to excess water inside the balloon cannot flow out through the dink eye.This has led to balloon lifting.This nonconformance will be documented in for further investigation and the action plan will be specified.

• Brand Name: 1616G LTX CATH 5 CC 2-WAY 16FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): COVIDIEN; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• MDR Report Key: 9604124
• Report Number: 9611712-2020-00101
• Device Sequence Number: 2416688
• Product Code: KOD
• UDI-Device Identifier: 10884521016286
• UDI-Public: 10884521016286
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1616
• Device Catalogue Number: 1616
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1