MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR IN LINE PRECISION VAVLE SG H; PRECISION VALVES WITH SG

Catalog Number 825465

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.Other mfg report number: 3013886523-2021-00284.A facility reported that two precision valves were explanted because they are not working.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

The precision valve was returned for evaluation.Device history record (dhr) - product code 82-5465 with lot 3959742, conformed to the specifications when released to stock.Failure analysis - the valve is a precision valve with 5 dots.The valve was visually inspected: no defects were noted.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.

• Brand Name: IN LINE PRECISION VAVLE SG H
• Type of Device: PRECISION VALVES WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12125265
• MDR Text Key: 260239127
• Report Number: 3013886523-2021-00285
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 825465
• Device Lot Number: 3959742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1