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

Catalog Number	INS5010
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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
An authorized distributor reported that it was difficult to insert the hermetic lumbar catheter, closed tip (ins5010) through the tuohy needle, as if the catheter had lost its elasticity.Additional information received as follows: 1.For how long did the dysfunction lead to increase surgery time? answer: it took more than an hour to secure the lumber drain (sterile technique before surgery).2.How did the medical team finish the procedure (using this unit or another one¿)? answer: drain inserted as planned preop.With difficulties, difficult to pass the silicon drain into spinal needle catheter (resistance) and, at the end, so difficult to remove the spinal needle while the catheter is in the spine, risking puncturing the silicon tube or causing its fracture.3.How is the patient now? answer: he is fine, however, the team didn't like the lumbar drain experience, and i feel it is so risky, especially if the drain fracture and piece left intraspinal.4.End user healthcare facility? answer: prince sultan military medical city in (b)(6) (saudi arabia).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter (ins5010) was not returned because the unit was discarded, and no photos were provided; therefore, failure analysis is not possible.Device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed, and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.Investigation findings: based on complaint report that the device was as ¿if the catheter had lost its elasticity¿.The tubing used for the manufacturing of this catheter was tested at incoming inspection, including tests for elongation and break load force.The tubing complied with all tests performed, and the tubing lot was used in 14 different finished goods lots (approximately 4,000 units) and no other complaint has been received related to the reported condition.As a result, a root cause determination is not possible since the catheter was not returned.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.

• 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: 23259913
• Report Number: 2648988-2025-00043
• Device Sequence Number: 12003568
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 7501100
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: Male