MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAF-T HOLDER BLOOD CULTURE W/FEMALE LUER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	96005
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that when disposing the safety holder in the needle disposal box, the healthcare provider was injured by the needle after forcibly pushing it.This event happened in the hospital setting.There was no disinfection or sterilization, and no infectious disease occurred.There was unknown patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.Reason device not evaluated by mfg: other; device was not returned to manufacture 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.The device has not been returned to the manufacturer.
Additional Manufacturer Narrative
H3: neither product nor pictures were received for analysis.The investigation could not confirm whether a healthcare professional experienced a needlestick injury during disposal of the saf-t holder, as the device was reportedly forced into a sharp's container with a narrow opening.Due to the lack of physical evidence and inability to verify the reported issue with confidence, no further action will be taken at this time.Complaint data will continue to be monitored for any new information or emerging trends, and appropriate actions will be taken if necessary.A device history record could not be completed as no lot number was received.

• Brand Name: JELCO SAF-T HOLDER BLOOD CULTURE W/FEMALE LUER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20833264
• Report Number: 1217052-2024-00218
• Device Sequence Number: 3863250
• Product Code: JKA
• UDI-Device Identifier: 00351688065592
• UDI-Public: (01)00351688065592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 96005
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/01/2025
• 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