MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL CL EVD 1.9MM CTH SET; BACTISEAL EVD CATHETERS

Catalog Number	821750
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bactiseal catheter 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(s) of the reported issue could not be determined, however, a possible root cause for the issue reported by the customer, could be due to manipulation of the device or a sharp or pointed object coming into contact with the device as noted in the ifu silicon has a low cut/tear resistance.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
1 of 2 reports.Other mfg report number: 3013886523-2024-00148.A facility reported leakage was found around a bactiseal post operative.No additional information was provided after several attempts.

• Brand Name: BACTISEAL CL EVD 1.9MM CTH SET
• Common Device Name: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19346838
• Report Number: 3013886523-2024-00147
• Device Sequence Number: 6492560
• Product Code: JXG
• UDI-Device Identifier: 10381780518457
• UDI-Public: 10381780518457
• Combination Product (Y/N): Y
• PMA/510(K) Number: K090348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 821750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/17/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 94622
• Patient Sequence Number: 1
• Patient Sex: Unknown