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

Catalog Number	EL31915
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe became blocked when the patient was injected.There was reported patient involvement, but no patient harm.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
D4: possible lot numbers: 25a014, 6002494, 4279250, 6064770.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO W/SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene ; GM
• Manufacturer Contact: reed covert ; 10 bowman drive; keene, NH 03431 ; 2247062300
• MDR Report Key: 23647135
• Report Number: 1217052-2025-00111
• Device Sequence Number: 14678220
• Product Code: FMI
• UDI-Device Identifier: 00351688072545
• UDI-Public: (01)00351688072545(17)291016(10)6064770
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: Other
• Device Catalogue Number: EL31915
• Device Lot Number: 6064770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 01/14/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/22/2026
• 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
• Patient Sex: Unknown