MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE; SYRINGE, PISTON

Model Number	4319
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	10/16/2020
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.Visual inspection of the unopened sample, revealed that the edge needle-pro was loose inside sealed package, not assembled to the syringe.While the detachment of the needle-pro device from the syringe is not desirable, the needle-pro device was easily reassembled to the syringe without removing the components from the sealed package.The issues that were described by the customer could not be reproduced with the returned samples.Therefore, the root cause could not be confirmed with the samples provided.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 during use of the device, the needle popped off the syringe.No patient injury was reported.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
• Common Device Name: SYRINGE, PISTON
• 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: 15326361
• Report Number: 3012307300-2022-16898
• Device Sequence Number: 14743107
• Product Code: FMF
• UDI-Device Identifier: 00351688052042
• UDI-Public: 00351688052042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• 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: 03/10/2025
• Device Model Number: 4319
• Device Catalogue Number: 4319
• Device Lot Number: 3958572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2020
• 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