MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number 828804PL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Dhr - lot 4837610 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the needle guard was raised.The valve passed the test for programming, leak, reflux, siphon guard and pressure.The valve was flushed; no occlusion was noted but the flow was difficult.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone housing base.The root cause for the problem reported by the customer is due to the raised needle guard this is probably due to wrong handling as noted in the ifu : do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway.

Event Description

2 of 2 reports.Other mfg report number: 3013886523-2021-00096.A surgeon reported an out of box failure of the certas valve.Issue detected before implantation.A minimal surgical delay was reported.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11388917
• MDR Text Key: 234254992
• Report Number: 3013886523-2021-00095
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828804PL
• Device Lot Number: 4837610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1