MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD IN LINE PRECISION VAVLE SG M; PRECISION VALVES WITH SG

Model Number	825463
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 patient id card for a programmable valve came attached to a precision valve.Surgeon had to check he was placing the correct valve, checking on a red sticker on the internal packaging stating non programmable valve, and also visually inspected the valve to ensure it was the correct valve.There was no consequences for the patient; few minutes surgical delay.
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation however, a picture was provided: dhr - no anomalies.Failure analysis: the product was not returned for investigation but based on the photos provided the complaint was confirmed.The hakim precision valve was delivered with id card for hakim programmable valve.Root cause: the investigation done through a non-conformance determined that the prior legal manufacturer (jnj) of this code had never complied with "international standard that governs requirements for sterile, single-use, non-active hydrocephalus components".

• Brand Name: IN LINE PRECISION VAVLE SG M
• Common Device Name: PRECISION VALVES WITH SG
• 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: 11859708
• Report Number: 3013886523-2021-00223
• Device Sequence Number: 3789429
• Product Code: JXG
• UDI-Device Identifier: 10381780520078
• UDI-Public: (01)10381780520078(17)250731(10)4933233
• Combination Product (Y/N): N
• PMA/510(K) Number: K992173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Expiration Date: 07/31/2025
• Device Model Number: 825463
• Device Catalogue Number: 825463
• Device Lot Number: 4933233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 12/13/2022
• Date Device Manufactured: 08/31/2020
• 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