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

Model Number	4285
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mw5105666, product was not returned for investigation.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.
Event or Problem Description
It was reported that when using a 20g x 1 " safety needle to make a sterile admixture, the needle assembly came apart and the needle flew across the isolator hood when air was expelled from the syringe.It is where the smaller hub connects to the larger hub where the needle came apart.
Additional Manufacturer Narrative
Mw5105666, product was not returned for investigation.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.
Event or Problem Description
It was reported that when using a 20g x 1 " safety needle to make a sterile admixture, the needle assembly came apart and the needle flew across the isolator hood when air was expelled from the syringe.It is where the smaller hub connects to the larger hub where the needle came apart.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-03571.The report was submitted in error.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO DEVICE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13551514
• Report Number: 3012307300-2022-03571
• Device Sequence Number: 5037020
• Product Code: FMI
• UDI-Device Identifier: 20351688046786
• UDI-Public: 20351688046786
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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 Expiration Date: 07/21/2025
• Device Model Number: 4285
• Device Catalogue Number: 4285
• Device Lot Number: 4025875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown