MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL EVD CATHETER; BACTISEAL EVD CATHETERS

Catalog Number	821745
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported a hair was found inside the inner sterile package of an evd catheter (id 821745).Package remained sealed and a new one opened.No surgical delay, no patient harm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d8, d9, g6, h1, h2, h3, h6, h8, h11.The evd catheter (id 821745) was not returned for evaluation, but a photo was provided and evaluated: showing the presence of what looks like hair inside the sealed blister.Device history record (dhr) - the product code 821745 with lot 7452307 conformed to specifications when released to stock failure analysis - after reviewing the photo provided by the customer, we can see the presence of what looks like hair inside the sealed blister.Root cause analysis - the root cause for the issue reported by the customer was due to a human error.The specs in the working instruction were not applied.An awareness training was performed.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• 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: 23037988
• Report Number: 3013886523-2025-00244
• Device Sequence Number: 10082462
• Product Code: JXG
• UDI-Device Identifier: 10381780515593
• UDI-Public: (01)10381780515593(17)250831(10)7452207
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233448
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 08/31/2025
• Device Catalogue Number: 821745
• Device Lot Number: 7452307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown