MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, OPEN TIP; N/A

Catalog Number	NL8508330
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hermetic lumbar catheter, open tip (nl8508330) was not returned for evaluation and lot number information has not been provided to facilitate device history record(dhr) review.Also, no unit or photos were provided to confirm the reported condition and determine a possible root cause.Additionally, incoming records for the luer connector could not be verified since lot number was provided; however, as part on the luer incoming inspection, it is required to verify the canula dimensions (length and outer diameter), and also the tip of canula is verified to be blunt with no burrs or sharp edges (the canula is the part of the needle which is inserted in the catheter).Therefore, there are controls in place that verify possible defects that could provoke piercing/breakage of the catheter.If product is subsequently returned or 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
Medsun uf/importer report :(b)(4).Was received with the following information: "the neurosciences units (nicu, sp 6-3) are currently receiving a substitute lumbar drain product (nl8508330) that contains a rigid metal connector piece instead of a flexible plastic connector found in the standard ld (lumbar drain) kit.This item connects the catheter to the drainage system and is suspected to be causing punctures in the lumbar drains, contributing to over drainage of csf.These safety events have occurred twice in the recent month and no patient harm occurred.Rn went to see her patient in room 7120, at 12am to t&p and bath patient.At that time patient was intact and lumbar drain was intact with no drainage noted.[redacted name] went back in at 1am to assess the patient, and again patient remained intact and no evidence of drainage from lumbar drain.At 1:40am she returned to assess her patient which then she noted patient bone flap was sunken in, which was different than her 1am exam.Bone flap at that time appeared normal, rounded.[redacted name] questioned why the sudden change in bone flap appearance and realized there was a significant amount of clear drainage noted on the patient's pillowcase as well as the dressing of the lumbar drain and on the bed.She immediately notified the provider outside the room who came to the bedside and clamped the drain.They then notified neurosurgery who came to replace the lumbar drain and drainage system.The metal portion (hub) of the lumbar drain had punctured through the tubing of the drainage system.The system in question was sequestered.This incident has occurred before with this product and has been investigated quite extensively.This current product is a backup product for the preferred lumbar drain which is on back order.Situation - lumbar drain was noted to be punctured by the metal hub which is part of the drainage system causing extensive csf drainage.Assessment - rn assessed her patient at 1am with no signs of leakage and patient's bone flap remained w/in normal limits.40mins later she returned to the patient's room to find the patient's bone flap sunken in with significant clear fluid noted on the patient's pillowcase, dressing and the bed.She immediately called the provider to the bedside who then clamped the drainage system.Background - this particular lumbar drain has a metal hub that is used to connect to the drainage system.This metal hub is puncturing the tubing thereby causing the leakage.This is a known problem with this system and has been researched and arched up through supply chain.Recommendation - continue to bring this concern forward to supply chain and find an alternative product without the metal hub." additional information received indicating the following: 1.What is the lot/serial numbers of the reported device? unknown 2.Did patient(s) experience any signs/symptoms relative to the overdrainage? unknown 3.What action was taken after the product problem occurred? (e.G.Replacement of device, etc.) replacement of device.

• Brand Name: HERMETIC LUMBAR CATHETER, OPEN TIP
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20803048
• Report Number: 2648988-2024-00043
• Device Sequence Number: 9941269
• Product Code: JXG
• UDI-Device Identifier: 10381780072393
• UDI-Public: 10381780072393
• 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: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NL8508330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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