MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL CATHETER KIT

Catalog Number	823072
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Local Reaction (2035)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
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
2 of 3 reports.Other mfg report numbers: 3013886523-2023-00298, 3013886523-2023-00300.It was reported a patient developed severe rash and erythema along the shunt tract which persisted for many months despite antibiotic treatment and antihistamine treatment.The hakim valve and catheters were implanted on (b)(6) 2017 and the symptoms started in (b)(6) 2022.
Additional Manufacturer Narrative
Additional information received: "the distal bactiseal catheter has already been explanted many months ago when problem first identified.All other tubing remains in place.We won't know until allergist patch tests hence the need for the information.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal catheter kit was not returned for evaluation; 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(s) of the reported issue could not be determined.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
N/a.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: BACTISEAL CATHETER KIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17691351
• Report Number: 3013886523-2023-00299
• Device Sequence Number: 6116564
• Product Code: JXG
• UDI-Device Identifier: 10886704041313
• UDI-Public: (01)10886704041313(17)180430(10)141667
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 823072
• Device Lot Number: 141667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 10/03/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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