MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. ALL PURPOSE CATHETER STR 14; MULTIPLE UROLOGICAL CATHETERS

Model Number	IPN052065
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Cuts as you insert and makes customer bleed.Did not state if they needed medical attention.Additional information: medical attention not noted in this case.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Additional Manufacturer Narrative
Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and 100% inflation/deflation test was conducted.There was no sample returned and no photo received to help with the investigation.Sharp catheter that causes sut at insertion could not be visualized without returned sample.There was no sample returned and no photo received to help with the investigation.Simulation test on production sample also found no similar defect therefore complaint could not be further determined with limited information.
Event or Problem Description
Cuts as you insert and makes customer bleed.Did not state if they needed medical attention.Additional information: medical attention not noted in this case.

• Brand Name: ALL PURPOSE CATHETER STR 14
• Common Device Name: MULTIPLE UROLOGICAL CATHETERS
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15245052
• Report Number: 8040412-2022-00240
• Device Sequence Number: 4768036
• Product Code: KOD
• UDI-Device Identifier: 04026704304011
• UDI-Public: 04026704304011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: Health Professional
• Device Model Number: IPN052065
• Device Catalogue Number: 351014
• Device Lot Number: KMA22B0084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown