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

Model Number 27219-1

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10856930
• MDR Text Key: 216863238
• Report Number: 9612501-2020-01741
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00763000030964
• UDI-Public: 00763000030964
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27219-1
• Device Catalogue Number: 27219-1
• Device Lot Number: 0219927059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2020
• Date Device Manufactured: 04/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1