MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	06/17/2020
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
This is 1 of 3 reports linked to mfg report numbers: 3013886523-2025-00125 3013886523-2025-00126 event from a post-market clinical program: a facility reported a hakim valve (id 823832), a ventricular bactiseal catheter (id 823073) and a peritoneal bactiseal catheter (id 823074) were implanted on (b)(6), 2020.The patient was admitted to the pediatric immunology and nephrology department for treatment on (b)(6), 2020.The chief complaint was intermittent fever and cough more than half a month.After treatment, the child's fever gradually improved, but the subcutaneous effusion in the occipital region did not improve.Therefore, on (b)(6), 2020, an exploration and adjustment of the occipital cistern shunt tube was performed.The operation went smoothly.After the operation, local compression bandaging was given, and the child recovered smoothly and was discharged from the hospital.On (b)(6), 2020, the patient had recurrent fever, and on (b)(6), 2020, the 0mnay sac was implanted and the ventricle was performed under general anesthesia.The abdominal shunt tube removal surgery went smoothly.Anti-infection, anti-inflammatory and antifever treatment, as well as fluid replacement therapy were given.Later, there was no fever.The child was conscious, in good spirits, had a good appetite, normal defecation and urination, and could move the limbs freely.The anterior fontanelle was not closed and slightly collapsed.It has improved without any aftereffects.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The peritoneal bactiseal catheter (id 823074) was not returned for evaluation as the product is not available for return as per customer; 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, however, the possible root cause for the "fever¿ reported by the customer, could be linked to the patient and hospital surroundings.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: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• 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: 22159002
• Report Number: 3013886523-2025-00127
• Device Sequence Number: 7369286
• Product Code: JXG
• UDI-Device Identifier: 10886704041337
• UDI-Public: (01)10886704041337(17)200731(10)3714333
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/25/2025

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: 07/31/2020
• Device Catalogue Number: 823074
• Device Lot Number: 3914333
• 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: 05/18/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2019
• 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: Required Intervention
• Patient Age: 11 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian