MAUDE Adverse Event Report: COVIDIEN LLC DELTA VALVE, NEONATAL, PERFORMANCE LEVEL 1.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27219-1
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
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 it seemed that the ventricular connection site was much shorter than it was supposed to be.The facility was currently ceasing all use of the valves.Additional information received reported that just by looking at the valve in the sterile packaging, there was a distinct difference between the two connectors.The distal connector was much longer than the proximal connector.

• Brand Name: DELTA VALVE, NEONATAL, PERFORMANCE LEVEL 1.0
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 10856742
• Report Number: 9612501-2020-01736
• Device Sequence Number: 910173
• Product Code: JXG
• UDI-Device Identifier: 00763000030964
• UDI-Public: 00763000030964
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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: 03/28/2025
• Device Model Number: 27219-1
• Device Catalogue Number: 27219-1
• Device Lot Number: 0219927059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1