MAUDE Adverse Event Report: COVIDIEN LLC EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80CM, OPEN TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while placing the catheter through the needle, the catheter broke, leaving the tip in the patient.The patient's status was okay.

• Brand Name: EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80CM, OPEN TIP
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 11879327
• Report Number: 9612501-2021-00846
• Device Sequence Number: 19114616
• Product Code: JXG
• UDI-Device Identifier: 00763000027278
• UDI-Public: 00763000027278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 09/12/2025
• Device Model Number: 46420
• Device Catalogue Number: 46420
• Device Lot Number: 0220884648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1