MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	4288
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
2/4 reference (b)(4) for all the related complaints and attachments while injecting patient with medication, medication did not disperse into patient joint, but instead came out of the side of the needle.Needle was checked with syringe to ensure that it was on properly and needle/syringe lined up and was as tight as possible.

• Brand Name: JELCO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11255619
• Report Number: 3012307300-2021-00734
• Device Sequence Number: 3718010
• Product Code: FMI
• UDI-Device Identifier: 20351688046809
• UDI-Public: 20351688046809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2021

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: 11/20/2018
• Device Model Number: 4288
• Device Catalogue Number: 4288
• Device Lot Number: 3724124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1