MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAF-T WING BLOOD COLLECTION AND INFUSION SE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	982112D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
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.Visual and functional testing were performed.One sample was received in used conditions, within its original sealed package inside a plastic bag.The returned sample was visually inspected to 12" to 16: and normal conditions of illumination.No damage or broke components were found in the returned sample.The product sample met all specifications.The reported issue was not confirmed.The root cause of the reported issue could not be determined.No corrective actions are required since the customer complaint was not confirmed.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 device hub was bending or breaking, which happens after multiple usages.Also, there was a report of the butterfly needle sets exploding.The rubber stopper prevented blood from coming out when there is not a tube pressed into the needle for filling.No patient injury was reported.

• Brand Name: JELCO SAF-T WING BLOOD COLLECTION AND INFUSION SE
• 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: 15327212
• Report Number: 3012307300-2022-16986
• Device Sequence Number: 17486567
• Product Code: FMI
• UDI-Device Identifier: 20351688081756
• UDI-Public: 20351688081756
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2026
• Device Model Number: 982112D
• Device Catalogue Number: 982112D
• Device Lot Number: 4110214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• 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: 04/18/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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