MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAR-T WING, 23 GAUGE,; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	972312
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	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).H3 - other: device has not been returned to date.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.One photo of the product packaging was sent in; however the reported failure mode cannot be seen in the photo.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported from the user facility: "another member of staff has had a similar near-miss event this week when again in the process of removing the cellophane sleeve, the cap of the needle dislodged." the defective device is not available.No patient involvement.

• Brand Name: JELCO SAR-T WING, 23 GAUGE,
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19273703
• Report Number: 3012307300-2024-03519
• Device Sequence Number: 7494976
• Product Code: FMI
• UDI-Device Identifier: 00351688059980
• UDI-Public: (01)00351688059980(17)270620(10)4295299
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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: 972312
• Device Lot Number: 4295299
• 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: 04/12/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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