MAUDE Adverse Event Report: ICU MEDICAL, INC. HYPO NEEDLE-PRO 19G; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	EL1915
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
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 information becomes available.
Event or Problem Description
It was reported that there was a detached needle.An australian pharmacy (facility details not provided) reported incident involving olanzapine depot injection where a faulty needle was identified after administration.A patient came in for their regular monthly olanzapine 405 mg injection.The injection was prepared and given as usual.After the injection, the needle came off the syringe, leaving the needle in the patient.The needle was safely removed, and the patient was not harmed.The needle was disposed of by the pharmacy after use and was not retained.
Additional Manufacturer Narrative
G1 - mfg contact office address 1, g1 - mfg contact office city, g1 - contact office region state, and g1 - contact office zip code: correction.H6.Codes: updated.One (1) photo provided for evaluation; one (1) photo provided, confirms the complaint of the needle becoming detached.No product was returned for evaluation.The reported complaint can be confirmed from the photo provided.However, the root cause was unable to be determined.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: HYPO NEEDLE-PRO 19G
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 10 bowman dr; keene, NH 03431 ; 2247062300
• MDR Report Key: 24158150
• Report Number: 1217052-2026-00001
• Device Sequence Number: 9205221
• Product Code: FMI
• UDI-Device Identifier: 20351688075670
• UDI-Public: (01)20351688075670(17)270428(10)4279250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: EL1915
• Device Lot Number: 4279250
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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