MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VAVLE MICRO W RICKHAM; CHPV

Catalog Number	823116
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported the connection part of a hakim valve reservoir is likely to fall out.The reservoir is uneven, therefore, it was replaced with a new product.The event led to 30 minutes surgical delay.The issue was confirmed during the implantation procedure, before implantation site closure.
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.
Additional Manufacturer Narrative
Hakim valve reservoir (id 823116) was returned for evaluation.Device history record (dhr) - lot 6863452 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 110 mmh2o.The valve was visually inspected and no defects were noted.The valve passed the test for occlusion, leak, reflux, and pressure.Root cause analysis - 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 improper handling of the device.At the time of investigation, no function issues were noted.

• Brand Name: PROG VAVLE MICRO W RICKHAM
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18160755
• Report Number: 3013886523-2023-00388
• Device Sequence Number: 17945842
• Product Code: JXG
• UDI-Device Identifier: 10381780519195
• UDI-Public: (01)10381780519195(17)271130(10)6863452
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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 Catalogue Number: 823116
• Device Lot Number: 6863452
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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