MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BEVD 1.9MM CAT SET; BACTISEAL EVD CATHETERS

Catalog Number	821749
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported an expired bactiseal catheter (id (b)(4) was placed after the expiration date on may 31, 2024.The expiration date was checked prior to placement and the physician decided to proceed.The device is still on the patient and has not been removed.The patient did not experience any signs or symptoms due to the expired device.According to information provided, the purchase date of the device is unknown.
Additional Manufacturer Narrative
The bactiseal catheter (id (b)(4) was not returned for evaluation as the product was implanted; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause for the reported issue is due to the physician choosing to implant the device even after checking the expiry date prior to implantation.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: CODMAN BEVD 1.9MM CAT 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: 19621200
• Report Number: 3013886523-2024-00187
• Device Sequence Number: 8121418
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: (01)10381780518440(17)240531(10)7253750
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 821749
• Device Lot Number: 7253750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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