MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; HYPDERMIC NEEDLE

Model Number	25 GAUGE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical sharps safety|jelco hypodermic needle-pro needle reported incident of " needle broke in patient's arm.".
Additional Manufacturer Narrative
Device evaluation- eighty-four unused samples were returned for evaluation.Visual inspection was performed and no defects were identified.Half of the returned samples were given simulated use testing.The devices were assembled as per device instructions: the needle-pro safety devices were attached to syringes and needles attached to syringes.The assembled devices were then tested by inserting the needles into medication vials, withdrawing fluid and then using the syringes to inject fluid.During this testing no leakage or component detachment occurred.The samples were tested for needle breakage; the testing showed the samples met with specifications for minimum required force to separate the needle from the needle hub.The samples were found to perform as specified.

• Brand Name: JELCO
• Common Device Name: HYPDERMIC NEEDLE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11059421
• Report Number: 3012307300-2020-12681
• Device Sequence Number: 2684510
• Product Code: FMI
• UDI-Device Identifier: 20351688046816
• UDI-Public: 20351688046816
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: No Information
• Device Expiration Date: 05/21/2025
• Device Model Number: 25 GAUGE
• Device Catalogue Number: 4291
• Device Lot Number: 4002117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1