MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Model Number	82-8804PL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported the certas valve seem to have a leak.No additional information has been provided.
Additional Manufacturer Narrative
Updated fields:  b1, b2, d1, d2a, d4, d6a, d6b, d9, g3, g6, h1, h2, h3, h6, h10 the certas valve (id 828800pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 5.The valve was hydrated.The valve was visually inspected; needle holes in the needle chamber were noted one of the needle holes was quite large.The valve was leak tested and only leaked from the needle hole in the needle chamber.The complaint is confirmed.The root cause for the issue reported by the customer is could be due to user, using the wrong needle, as noted in the ifu, if hypodermic injection is required, inject with a 25-gauge or smaller non-coring huber type needle into the reservoir only additional information received: patient injury: no action or procedure being performed.Lumbar peritoneal shunt actions taken: replaced device did the patient experienced any signs and symptoms? no.
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Common Device Name: CERTAS PLUS
• 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: 14162014
• Report Number: 3013886523-2022-00178
• Device Sequence Number: 12201412
• Product Code: JXG
• UDI-Device Identifier: 10886704079040
• UDI-Public: 10886704079040
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 82-8804PL
• Device Catalogue Number: 828800PL
• Device Lot Number: 4601015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown