MAUDE Adverse Event Report: RAYNHAM BACTISEAL BARIUM STRIPED CATH; BACTISEAL CATHETER KIT

Model Number	NS0340
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	02/08/2023
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
A physician reported a bactiseal catheter (id: ns0340) was implanted via v-p (ventricular peritoneal) shunt on unknown date.On an unknown date, shunt failure was suspected due to suspicion of cerebrospinal fluid leakage.The bactiseal catheter was removed and replaced on (b)(6) 2023.
Additional Manufacturer Narrative
Bactiseal catheter (id ns0340) has been returned for evaluation: failure analysis- the catheter was visually inspected, no defect was noted.The catheter was irrigated, no occlusion noted.The catheter was leak tested, no leaks were noted.The catheter functions.Root cause - no root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction: d9 - returned to manufacturer.

• Brand Name: BACTISEAL BARIUM STRIPED CATH
• Common Device Name: BACTISEAL CATHETER KIT
• 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: 16426385
• Report Number: 3013886523-2023-00062
• Device Sequence Number: 2620221
• Product Code: JXG
• UDI-Device Identifier: 10886704045175
• UDI-Public: 10886704045175
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: NS0340
• Device Catalogue Number: NS0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 07/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/03/2023; 07/27/2023
• 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