MAUDE Adverse Event Report: Integra LifeSciences Mansfield CODMAN BACTISEAL CATHETER KIT

Catalog Number	823072
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
6 of 7 reports (same facility/surgeon, 3 patients, 7 revisions).Other mfg report numbers: 3013886523-2026-00211 3013886523-2026-00212 3013886523-2026-00213 3013886523-2026-00214 3013886523-2026-00215 3013886523-2026-00217 this report is for patient 3/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions.2 patients were somewhat obese, 1 had +/- normal weight.Therefore, the catheter was explanted.No additional information has been provided after several attempts.
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.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: Bactiseal
• 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 ; +1(609)936-2319
• MDR Report Key: 50374202
• Report Number: 3013886523-2026-00216
• Device Sequence Number: 9883931
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: 10381780515616
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 823072
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown