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

Model Number	821749
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bactiseal catheter was not returned for evaluation (as per customer, product not available); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined; however, a possible root cause for the issue reported by the customer, could be due to a sharp or pointed object coming into contact with the device, as noted in the ifu silicone has a low cut/tear resistance.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.
Event or Problem Description
A facility reported a bactiseal catheter (id 821749) was implanted on (b)(6) 2022.The catheter was broken and leaking minimal cerebrospinal fluid (csf) nine days after the procedure.The patient had a little higher body temperature.Therefore, the catheter was removed and monitoring was stopped.The patient recovered after the treatment and was discharged.

• 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: 16158889
• Report Number: 3013886523-2022-00595
• Device Sequence Number: 7051888
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: (01)10381780518440(17)230731(10)6534931
• Combination Product (Y/N): N
• PMA/510(K) Number: K090348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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 Expiration Date: 07/31/2023
• Device Model Number: 821749
• Device Catalogue Number: 821749
• Device Lot Number: 6534931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2022
• Initial Report FDA Received Date: 01/13/2023
• Date Device Manufactured: 08/16/2022
• 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