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

Catalog Number	402558
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pediatrics team had been experiencing needles falling off prefilled syringes ¿ specifically for flu shot syringes.Needles seemingly unscrewed themselves and fell off.The event occurred during removal/ at the end of therapy.There was no medical intervention required.There was no patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
H3: no product was returned but a picture was received for analysis.The complaint of needles falling off prefilled syringes cannot be confirmed based on the returned images.Without the return of the sample used a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.
Additional Manufacturer Narrative
D3 - mfg establishment name and address: corrected.H3 and h6 codes - updated.The complaint cannot be confirmed based on the returned images.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.It is not anticipated that the reported malfunction would result in interruption of therapy or serious injury.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO EDGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21687820
• Report Number: 3012307300-2025-03219
• Device Sequence Number: 9420171
• Product Code: FMI
• UDI-Device Identifier: 00351688066520
• UDI-Public: (01)00351688066520(10)5036370
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: Health Professional
• Device Catalogue Number: 402558
• Device Lot Number: 5036370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 02/24/2025; 01/30/2026
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 02/06/2026; 02/11/2026
• 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