MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Catalog Number	823045
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2025
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
The physician reported a hakim peritoneal catheter (id (b)(6)) was implanted due to noncommunicating hydrocephalus via ventriculoperitoneal (vp) shunt on unknown date.The catheter was leaking, therefore it was removed and replaced on (b)(6) 2025.No damage was observed with visual inspection.According to information provided, the estimated amount of cerebrospinal fluid (csf) leakage is unknown.It is unknown if the patient experienced any signs and symptoms due to product problem.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim peritoneal catheter (id 823045) was returned for evaluation.Device history record (dhr) - the product code 823045 with lot 7344361, sn unknown, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected; no defects noted.The catheter was leak tested, no leak was observed.The catheter was irrigated, no occlusions was noted.The complaint was not confirmed.Root cause analysis - no root cause could be determined.As noted in the investigation, no leakage was noted with the returned 730mm catheter.The possible root cause for the issue reported by the customer could not be clearly determined as only 730mm catheter of the 1200mm were returned.The issue could be linked 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: HAKIM PERITON CATH,120CM
• Common Device Name: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23154495
• Report Number: 3013886523-2025-00251
• Device Sequence Number: 10146007
• Product Code: JXG
• UDI-Device Identifier: 10381780518839
• UDI-Public: (01)10381780518839(17)281231(10)7344361
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 823045
• Device Lot Number: 7344361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown