MAUDE Adverse Event Report: RAYNHAM CODMAN LUMBER CATHETER KIT; SHUNT, NERVOUS SYSTEM & COMPS

Model Number	82-1707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 facility reported a lumbar catheter kit (id 821707) drain broke in patient upon insertion and the patient was imaged under fluoroscopy, an incision was made in the lumbar region to remove the broken piece, then irrigated out and closed.The patient was imaged after and confirmed all pieces were removed.
Additional Manufacturer Narrative
The lumbar catheter ((b)(4)) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a visual inspection confirmed a broken/torn drain tube, unable to perform functional testing due to broken product, and the device did not meet the specifications.Therefore, the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could confirm the complaint.
Event or Problem Description
N/a.

• Brand Name: CODMAN LUMBER CATHETER KIT
• Common Device Name: SHUNT, NERVOUS SYSTEM & COMPS
• 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: 16515868
• Report Number: 3014334038-2023-00029
• Device Sequence Number: 14984772
• Product Code: JXG
• UDI-Device Identifier: 10886704040811
• UDI-Public: 10886704040811
• Combination Product (Y/N): N
• PMA/510(K) Number: K964923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 01/31/2024
• Device Model Number: 82-1707
• Device Catalogue Number: 821707
• Device Lot Number: J2604M
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2019
• 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