MAUDE Adverse Event Report: RAYNHAM CODMAN BEVD 1.9MM CAT SET; BACTISEAL EVD CATHETERS

Model Number	821749
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a bactiseal catheter (id 821749) was leaking minimal cerebrospinal fluid (csf) during the procedure.The leakage was in the white tip of the device at the connecting point.The issue was detected before implantation site closure.The procedure was completed with a replacement product and 1 hour delay was noted.
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.
Additional Manufacturer Narrative
The bactiseal catheter (id 821749) was returned for evaluation.Device history record (dhr) - lot 5847395, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected; 2 holes/cuts/tears in the connecting end of the catheter were noted.Complaint confirmed.The possible root cause for the issue reported by the customer could be due to a handling or a sharp or pointed object coming into contact with the catheter, as noted in the "ifu" silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: CODMAN BEVD 1.9MM CAT SET
• Common Device Name: BACTISEAL EVD CATHETERS
• 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: 15001126
• Report Number: 3013886523-2022-00323
• Device Sequence Number: 1562622
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: (01)10381780518440(17)220930(10)5847395
• Combination Product (Y/N): N
• PMA/510(K) Number: K090348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/07/2022

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: 09/30/2022
• Device Model Number: 821749
• Device Catalogue Number: 821749
• Device Lot Number: 5847395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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