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

Catalog Number	4288
Medical Device Problem Code	Fluid/Blood Leak (1250)
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: month and year of event have been provided; day is unknown.H3: device 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 injection leaked at the hub with two different needles during the process.The third attempt succeeded.The procedure was completed after applying and testing a third needle on the syringe.The leaking was noted while drawing up medication into the syringe, prior to injection.The patient¿s skin was not punctured until there was confirmation that the needle was not leaking at the hub after attaching the 3rd needle.
Additional Manufacturer Narrative
D3: mfg.Establishment name updated.H3: no device or device photo was returned for investigation.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.If the product is returned, this complaint will be reopened for further investigation.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22030228
• Report Number: 3012307300-2025-05748
• Device Sequence Number: 15484589
• Product Code: FMI
• UDI-Device Identifier: 20351688046809
• UDI-Public: (01)20351688046809(17)291107(10)6068020
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 4288
• Device Lot Number: 6068020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEPOMEDROL; LIDOCAINE; ROPIVACAINE
• Patient Age: 22 YR
• Patient Sex: Male