MAUDE Adverse Event Report: COVIDIEN 1614G LTX CATH 5CC 2-WAY 14FR; CATHETER, UROLOGICAL

Model Number	1614
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the balloon was not able to deflate and the catheter had to be cut in order to remove it.
Additional Manufacturer Narrative
Evaluation summary the device history record (dhr) review could not be retrieved as the returned sample was not in complete condition.The funnel part of the catheter where the identifying mark is printed, was not attached to the catheter.Without this information, a dhr will not be available as the lot number unknown.A sample was received for evaluation.The sample that was received was cut at the shaft area a to be removed from the patient.However further investigation had been conducted.The sample was subjected to an inflation test.It was observed that the sample was not able to be inflated as per normal practice due to a leakage on the balloon.The leakage is suspected from the use of cutter during the removal process of the sample.Thus, the reported condition could not be confirmed because further investigation cannot be conducted as the sample received was not in its complete condition.A root cause could not be determined as the sample was not in actual condition that permitted for further investigation.Since no negative trend exists, an actual root cause for the reported condition cannot be specifically identified; therefore, corrective and preventative action (capa) will be limited to the manufacturing awareness.No further corrective action is required at this time.This complaint will be recorded for tracking and trending purpose.

• Brand Name: 1614G LTX CATH 5CC 2-WAY 14FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): COVIDIEN; padang lati, mukim; paya; kangar, perlis ; MY
• MDR Report Key: 9593312
• Report Number: 1282497-2020-08867
• Device Sequence Number: 3654408
• Product Code: KOD
• UDI-Device Identifier: 10884521016224
• UDI-Public: 10884521016224
• 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): 03/16/2020

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: 1614
• Device Catalogue Number: 1614
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/16/2020
• Patient Sequence Number: 1