MAUDE Adverse Event Report: INTEGRA - PRINCETON HERMETIC LUMBAR CATHETER, CLOSED TIP; N/A

Catalog Number	INS5010
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
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 following regarding the hermetic lumbar catheter, closed tip (ins5010): "disconnection of the catheter from the deliquoration set for a non-pressure catheter lumen and no stop applied an external suture thread without benefit." additional information was subsequently received with the following information: could you please confirm that the issue was that the catheter disconnected from the bag of csf even it was sutured properly and there was no tension on it? yes date the catheter was inserted? (b)(6)2025.Date the catheter was discovered disconnected? (b)(6) 2025.Which action was done to resolve the issue (change the catheter, new sutures¿)? catheter removal.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter (ins5010) was not returned, and no photos of the disconnected components were provided.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.It is unknown if the flexible luer adapter provided with the catheter was used or some other type of connector.The mode of disconnection is not explained.A possible disconnection site could be the catheter connector luer from the external drainage system (deliquoration set); however, it seems that the catheter disconnected from the connector itself based on the mention of suture threads.As per product ifu: the silicone elastomer tubing should be carefully secured to the connector with ligatures in such a manner as to avoid cutting of the tubing.The reported unit has not been received for evaluation; therefore, a root cause determination is not possible at this moment.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21766616
• Report Number: 2648988-2025-00008
• Device Sequence Number: 8491085
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: 10381780071082
• Combination Product (Y/N): N
• PMA/510(K) Number: K972994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: INS5010
• Device Lot Number: 7461011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2024
• 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
• Patient Sex: Unknown