MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823162

Device Problem Packaging Problem (3007)

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

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

2 of 2 reports.Same procedure, different products.Other mfg report number: 3013886523-2021-00130 a facility reported a damaged package of a hakim valve.During procedure, the nurse found that the package of the valve was damaged.Therefore, the physician stop implanting it and changed to a new hakim valve and the procedure was completed.A 15 minute delay was noted with no adverse consequence to the patient.

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The valve was returned for evaluation.Device history record (dhr) - product code 82-3162 with lot 3214676, conformed to the specifications when released to stock.Failure analysis - it was not possible to investigate as only the valve was returned in a plastic tub no packaging was returned for investigation.As no defect was reported on the valve this was not investigated.No root cause could not be determined as the no packaging was returned for investigation.The possible root cause for the packaging issue reported by the customer could be due to handling/storage/transport.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11572343
• MDR Text Key: 243861693
• Report Number: 3013886523-2021-00131
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 823162
• Device Lot Number: 3214676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1