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

Catalog Number	4292
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the registered nurse (rn) administered an intramuscular injection to patient's right deltoid.Upon withdrawal, the needle was left behind in the patient's arm and the safety mechanism failed to remain intact.The rn removed the needle, and the patient jerked.Subsequently, the needle fell out of the rn's hand, leading to needle stick.The event did not result in patient harm.The event occurred in the patient's room during rn medication administration.
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.Investigation codes: updated.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• 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: 20598906
• Report Number: 1217052-2024-00169
• Device Sequence Number: 12997762
• Product Code: FMI
• UDI-Device Identifier: 20351688046854
• UDI-Public: (01)20351688046854(17)250817(10)4040670
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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 Expiration Date: 08/17/2025
• Device Catalogue Number: 4292
• Device Lot Number: 4040670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2020
• 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