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

Catalog Number 825464

Device Problem Fracture (1260)

Patient Problem Injury (2348)

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

1 of 2 reports.Other mfg report number: 3013886523-2020-00261.A facility reported a certas valve was implanted on (b)(6) 2020.On an unknown date, the child started to deteriorate (unknown symptoms) and on (b)(6) 2020 the valve was explanted.The medical staff discovered the valve had fractured at junction between valve and anti-siphon device.

Manufacturer Narrative

Udi ¿ (b)(4).The valve was not returned for evaluation (discarded) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The root cause for the issue reported by the customer is probably due to a sharp or pointed object coming into contact with the device, as noted in the ifu silicone has a low cut/tear resistance.

• Brand Name: IN LINE PRECISION VAVLE SG MH
• 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: 11045916
• MDR Text Key: 222645008
• Report Number: 3013886523-2020-00260
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

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 Catalogue Number: 825464
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1