MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO NEEDLE-PRO STANDALONE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4292
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the needle popped out and leaked when the vaccine was administered.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: 704 pieces of product 4292 were returned in unused condition.The actual device used at the time of the complaint, was not returned for investigation.Visual inspection did not reveal any defects or anomalies.All samples were unopened and within the original packages.Functional testing was performed of 80 devices.All results were acceptable with the samples remained assembled and no detachment observed.No leakage was observed during evaluation.The issue observed by the customer could not be reproduced with the returned samples.Therefore, the complaint could not be confirmed.A device history review found no discrepancies or anomalies relevant to the complaint.

• Brand Name: JELCO NEEDLE-PRO STANDALONE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21560250
• Report Number: 3012307300-2025-02633
• Device Sequence Number: 11855462
• Product Code: FMI
• UDI-Device Identifier: 20351688046854
• UDI-Public: (01)20351688046854(17)291016(10)6061980
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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 Catalogue Number: 4292
• Device Lot Number: 6061980
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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
• Patient Sex: Unknown