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

Catalog Number	NL8508330
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hermetic lumbar catheter, open tip (nl8508330) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause of the reported issue could not be determined.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 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
This report is related to mfg report number: 2648988-2024-00032 for 2nd patient that experienced the issue: a facility reported that the hermetic lumbar catheter (nl8508330) contains a rigid metal connector piece instead of a flexible plastic connector found in the standard lumbar drain kit.The item connects the catheter to the drainage system and is suspected to be causing punctures in the lumbar drains, contributing to over drainage of cerebrospinal fluid (csf).After the incident, the puncture was repaired and a separate connector was used from another lumbar drain kit.Patient experienced no symptoms from the overdrainage, and the follow up ct scans were not changed.Lumbar drain was kept clamped.No patient harm occurred.Medsun report#: (b)(4) 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 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.Room (b)(4) patient turned, straight cathed, and ld drained from 1830-1850, bedside report given, and at 1920 handoff of drips and drain performed, rn [redacted name] showed rn [redacted name] the ld and the 2 points of ld being clamped.Rn [redacted name] asked about flap and if it seemed more sunken (slightly) and asked to be shown the metal piece that punctured the tubing the previous night (great catch!!!!).The patient was turned slightly to show the piece and rn noticed a large amount of csf drained onto the sheets.Immediately clamped drain with kelly clamp and app to bedside, nsg to bedside, determined sharp metal piece punctured the white rubber tubing (same situation that had happened the night prior).Plan to replace drain with nsg and go to ct head.Patient exam remained stable, opened eyes spontaneously and wiggled toes.".

• 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: 20487216
• Report Number: 2648988-2024-00040
• Device Sequence Number: 4174209
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 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: 09/27/2024
• Initial Report FDA Received Date: 10/18/2024
• 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
• Patient Sex: Unknown