MAUDE Adverse Event Report: RAYNHAM BACTISEAL BARIUM STRIPED PERIT; BACTISEAL PERITONEAL CATHETER

Model Number	NS0339
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	10/27/2022
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
1 of 2 reports.Other mfg report number: 3013886523-2022-00543.A facility reported a certas valve (id 828804) was implanted via unknown shunt on unknown date / setting.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).And bactiseal peritoneal catheter (id ns0339 serial; unk).On (b)(6) 2022, the patient presented with disorientation and shunt imaging was performed.Ventricular enlargement was observed; therefore, shunt obstruction was suspected, and lumber catheter rupture was also confirmed the valve was removed and replaced on (b)(6) 2022.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id ns0339 serial;unk) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.The catheter was leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the catheter, at the time of investigation the no functional issues were noted with the catheter.

• Brand Name: BACTISEAL BARIUM STRIPED PERIT
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15753855
• Report Number: 3013886523-2022-00544
• Device Sequence Number: 2983728
• Product Code: JXG
• UDI-Device Identifier: 10886704045168
• UDI-Public: 10886704045168
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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 Model Number: NS0339
• Device Catalogue Number: NS0339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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