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

Model Number	IPN028499
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The clips shattered during procedure.No sample available.

• Brand Name: RANEY CLIPS DISPOSABLE 10/POUCH
• Common Device Name: CLIP, SCALP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12226377
• Report Number: 3003898360-2021-00638
• Device Sequence Number: 4672803
• Product Code: HBO
• UDI-Device Identifier: 34026704631811
• UDI-Public: 34026704631811
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: IPN028499
• Device Catalogue Number: 658505
• Device Lot Number: 3E2000388
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1