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

Model Number	4291
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	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation, however the actual product used at the time of the complaint, was not returned for investigation.Visual and functional testing were performed.Visual inspection did not reveal any defects or anomalies.Functional testing determined all results were acceptable.All samples functioned as intended and remained assembled throughout testing.No problem found.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.Operator of device is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the needles come out of the base of orange cap after being injected into patient's arm.The needle is then stuck in patient's arm.The needle was removed with no patient harm.No patient injury was reported.

• Brand Name: NEEDLE-PRO CARTRIDGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15312039
• Report Number: 3012307300-2022-16533
• Device Sequence Number: 6331153
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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
• Device Expiration Date: 02/18/2026
• Device Model Number: 4291
• Device Catalogue Number: 4291
• Device Lot Number: 4112030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown