MAUDE Adverse Event Report: INTEGRA - PRINCETON CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM; N/A

Catalog Number	INS1100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The csf drainage system with pole mount system (ins11000) was not returned for evaluation as the product was discarded per customer, and lot number has not been provided; therefore, device history records (dhr) could not be reviewed.In addition, no photos were provided for evaluation; therefore, a root cause determination for the reported condition is not possible, and the reported condition is considered unconfirmed.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
A facility reported the following occurred while the csf drainage system used with pole mount system (ins1100) was in use: ¿while in ct, patient's evd tubing spontaneously popped a hole and csf began to squirt out of tubing.Tubing had plenty of slack and the patient was not being moved at the time of the incident.Writer clamped evd, but csf was still leaking from the hole so writer taped the hole.Notified neuro icu pa and neurosurgery pa who said to clamp it proximally and the system would have to be replaced.Evd system was later replaced during dayshift.¿ subsequent information was also reported as follows: 1.Please provide patient's gender, ethnicity, and race.>> male, hispanic.2.Was there a delay in surgery due to product problem? if yes, how long? >> none reported.3.What is the lot/serial numbers of the reported devices? >> unknown, defective product was discarded.4.How much csf leaked during the incident (if an exact amount cannot be provided, please provide an approximate: small amount, moderate, etc.)? >> small/moderate amount.5.Please provide patient outcome, or status of the patient.>> stabilized and replaced with a new system during the dayshift.

• Brand Name: CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM
• 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: 19539253
• Report Number: 2648988-2024-00026
• Device Sequence Number: 17725745
• Product Code: JXG
• UDI-Device Identifier: 10381780071037
• UDI-Public: 10381780071037
• Combination Product (Y/N): N
• PMA/510(K) Number: K062599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: INS1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/14/2024
• 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: Male
• Patient Ethnicity: Hispanic