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

Catalog Number	821745
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2025
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 "the white connector of a bactiseal (which connects by screwing to the csf collect system) broke progressively.Csf leaked on the patient bandage and air entered in the brain.Neurosurgeon had to replace the connector.Risk of meningitis." additional information: it is mentioned that air entered the brain, as well as a risk of infection.Can you please indicate the symptoms observed and the consequences for the patient's health? "air was indeed observed in the evd tubing.A ct scan was not performed to determine whether there was air in the patient's brain, but it was a risk to be considered." what is the patient's current condition? "neurologically, the patient's condition was the same: precarious." you mention an intervention by the neurosurgeon: did the catheter have to be completely replaced, or just the tip? "no, too harmful for the patient, but the closed system represented by the catheter and the collection tubing was no longer so, presenting a high risk of infection." can you confirm if this was a procedure that required anesthesia? "no, no additional anesthesia." were additional tests necessary? "not immediately, but it was to be considered if the patient deteriorated.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The bactiseal catheter was returned for evaluation: dhr - despite several requests to the customer, the lot number of the product is unknown.A traceability of the reference 821745 has been performed and the device history records of the 9 lots, all conformed to the specifications when released to stock.Failure analysis -the connector was visually inspected, and a fracture was noted in one of the sides and at the luer taper end.Barb and luer taper end deformed.The complaint was confirmed.Root cause - the possible root cause for the issue reported by the customer could be due to a mishandling of the device as the it is severely deformed and/or due to excessive force used during the manipulation of the connector.
Event or Problem Description
N/a.

• 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: 22977784
• Report Number: 3013886523-2025-00238
• Device Sequence Number: 15747424
• Product Code: JXG
• UDI-Device Identifier: 10381780515593
• UDI-Public: (01)10381780515593(17)251031(10)7474719
• 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): 12/11/2025

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: 10/31/2025
• Device Catalogue Number: 821745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown