MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Catalog Number 544240

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for investigation.P/n 544240 is not being manufactured currently; however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted as follows: 20 samples were taken from the current production p/n 544230 hemolok l clips 6/cart 84/box, lot# 73c1900300, the samples were functionally inspected, and during the test issue reported, clip reopened on ureter was not observed in the current manufacturing process.The device history review could not be conducted since the lot number was not provided.The customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and to determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a donor nephrectomy patient had a bleed overnight and developed a hematoma after the procedure was completed.The patient was taken back to the operating room the following morning and the clip on the end of the ureter had opened.A small vessel aligned to the ureter was pulsing.The open clip was removed and discarded.Two new clips were placed and the patient recovered without incident.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 8475076
• MDR Text Key: 140666813
• Report Number: 3003898360-2019-00356
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention