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

Model Number	1614
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that when attempted to remove the catheter, the balloon was unable to deflate.Therefore, cutting the catheter was repeated, as the result the balloon deflated, and the catheter was able to be removed.There was no patient harm reported.
Additional Manufacturer Narrative
H3 evaluation summary.The device history record (dhr) for the reported lot number was reviewed.This lot was manufactured as per defined device master record.All acceptance criteria were met, and this batch was released meeting all the acceptance criteria.The sample was received at the plant.The sample was examined under a magnifying camera for physical inspection.A clamping mark was found on the shaft.The high-pressure clamping caused the balloon airline to constrict and collapse, and it was unable to perform deflation as intended.As the reported condition was not induced by the manufacturing process, further action is not required.Corrective action will be limited to manufacturing awareness of the issue.No further corrective action is required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 1614G LTX CATH 5CC 2-WAY 14FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): COVIDIEN; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• MDR Report Key: 10896167
• Report Number: 9611712-2020-00102
• Device Sequence Number: 11486745
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1