MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL BARIUM STRIPED PERIT; BACTISEAL PERITONEAL CATHETER

Model Number	NS0339
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.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 bactiseal barium peritoneal catheter (id: (b)(4)) was not seen under x-ray by surgeon and technicians.Several c arms and a digital x-ray were used, but had no success.There was a surgical delay for more than 30 minutes.The patient is in good condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Bactiseal peritoneal catheter (ns0339) was not returned for evaluation but an photo was provided.X-ray were provided showing that the catheters were found on the x-rays.This catheter only has a radiopaque striped line and is not completely radiopaque.This is the reason why it cannot be seen very well.Furthermore, for this kind of catheter, the visibility on x-rays depends on the striped line orientation.The root cause for the issue reported by the customer, could be due to the surgeon not being used to this product as this catheter only has a radiopaque striped line and the catheter is not completely radiopaque.

• Brand Name: BACTISEAL BARIUM STRIPED PERIT
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16379728
• Report Number: 3014334038-2023-00016
• Device Sequence Number: 5898848
• Product Code: JXG
• UDI-Device Identifier: 10381780524069
• UDI-Public: (01)10381780524069
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 09/30/2023
• Device Model Number: NS0339
• Device Catalogue Number: NS0339
• Device Lot Number: 6725035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/09/2023
• Date Device Manufactured: 10/17/2022
• 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