MAUDE Adverse Event Report: TELEFLEX MEDICAL RANEY CLIPS DISPOSABLE 10/POUCH; CLIP, SCALP

Model Number IPN028499

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product raney clips disposable 10/pouch lot# 73e2000388 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

The clips shattered during procedure.No sample available.

• Brand Name: RANEY CLIPS DISPOSABLE 10/POUCH
• Type of Device: CLIP, SCALP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 12226377
• MDR Text Key: 265571070
• Report Number: 3003898360-2021-00638
• Device Sequence Number: 1
• Product Code: HBO
• UDI-Device Identifier: 34026704631811
• UDI-Public: 34026704631811
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2021

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
• Device Operator: Health Professional
• Device Model Number: IPN028499
• Device Catalogue Number: 658505
• Device Lot Number: 3E2000388
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/27/2021
• 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