MAUDE Adverse Event Report: SMITHS MEDICAL ASD JELCO; 23G X 1" NEEDLE

Model Number	4290
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device needle and hub was not securely attached to the needle safety device, resulting in vaccine waste and needle remaining in patient arm.
Additional Manufacturer Narrative
Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes this safety syringe.The customer has already reported it to the fda.We have notified (b)(6) for awareness.

• Brand Name: JELCO
• Common Device Name: 23G X 1" NEEDLE
• Manufacturer (Section D): SMITHS MEDICAL ASD; keene; NH 03431
• Manufacturer (Section G): MCKESSON MEDICAL SURGICAL, INC; 1125 sycamore road; manteno IL 60950
• Manufacturer Contact: jo silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 12964235
• Report Number: 3017368639-2021-00190
• Device Sequence Number: 4389465
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: 20351688046823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 05/16/2024
• Device Model Number: 4290
• Device Catalogue Number: 4290
• Device Lot Number: 3799737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown