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

Catalog Number	402310
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needles fell off when they were given on patients.This happened after the administration of the devices and there were two needles reported having this issue.The patients were reported not to be impacted.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: 70 unused samples were received for investigation.Samples were visually and functionally tested and all samples passed the specification acceptance criteria.It is unknown what forces the device may have encountered during drawing up vaccines and hypodermic needle manipulation.The details of the clinical procedure were not provided.The breakage issues observed by the customer could not be reproduced with the returned samples.Based on the results of this investigation, this complaint could not be confirmed with the samples provided.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.Dhr reviews found no discrepancies or anomalies relevant to the complaint.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO EDGE
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20859330
• Report Number: 1217052-2024-00227
• Device Sequence Number: 3918379
• Product Code: FMI
• UDI-Device Identifier: 00351688066520
• UDI-Public: (01)00351688066520(17)270406(10)4275891
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K041399
• 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,Followup
• Report Date (Section B): 02/13/2025

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: 402310
• Device Lot Number: 4275891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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