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

Model Number	82-1707
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a lumbar catheter (id 821707) was used on a lumbar insertion and the tip of the catheter shredded apart once it was inserted into the patient.All visible parts were recovered.No patient injury reported.Surgical delay was reported; however, it is unknown for how long.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The codman lumber catheter was not returned for evaluation.Device history record (dhr) review - the batch record was reviewed for any anomalies or ncs related to the finished lot (j57g69), and it is noted that no anomalies occurred during the manufacturing process.Failure analysis - product was not returned to the analysis site for failure analysis due to shipping/logistics difficulties, however photos were provided of the product for analysis, and the following was performed on the provided photos: in the photos provided, there is visible damage to one end of the catheter, confirming the customer¿s complaint of the product ¿shredding¿ apart.The complaint was confirmed in the complaint investigation.The possible root causes include inadequate tip to catheter bond strength or incorrect surgical technique.

• 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: 15065723
• Report Number: 3014334038-2022-00159
• Device Sequence Number: 5504198
• 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): 10/19/2022

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: 09/30/2024
• Device Model Number: 82-1707
• Device Catalogue Number: 821707
• Device Lot Number: J57G69
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/19/2022
• Date Device Manufactured: 10/11/2019
• 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