MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. JELCO SAF-T WING BLOOD DRAW W/HOLDER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	982312D
Medical Device Problem Code	No Fail-Safe Mechanism (2990)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was stated that a sharps exposure occurred because the safety mechanism on a butterfly needle did not engage properly.The mechanism of injury was that, while attempting to engage the safety mechanism, the individual got their fingertip stuck.Upon testing, the safety mechanism felt tighter than usual and stopped halfway through the slide.It could be engaged with a strong pull, but it was noticeably tighter than other devices.This incident resulted in a needlestick injury.The fault was identified during testing, and no medical intervention was required.There was no patient involvement and no patient harm.

• Brand Name: JELCO SAF-T WING BLOOD DRAW W/HOLDER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22786901
• Report Number: 3012307300-2025-09570
• Device Sequence Number: 15963902
• Product Code: FMI
• UDI-Device Identifier: 20351688081770
• UDI-Public: (01)20351688081770(17)151129(10)6071827
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: 982312D
• Device Lot Number: 6071827
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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
• Patient Sex: Unknown