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

Model Number	402515
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual needles used at the time of the complaint were not returned for investigation.Unopened samples of the same lot number were received for investigation.Functional testing was done for patency by using a pin gauge.All samples passed.All samples were also tested by drawing up water through the needle and all performed as expected.The reported problem could not be confirmed based on the unused samples returned.A device history record (dhr) review found no discrepancies or anomalies relevant to the complaint.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that while injecting the patient with depo, the needle became clogged half way through.A different needle of the same lot was tried and it also clogged.The user did a test with water and it clogged too.No patient injury was reported.

• Brand Name: HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
• 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: 15320272
• Report Number: 3012307300-2022-16710
• Device Sequence Number: 20134547
• Product Code: FMI
• UDI-Device Identifier: 00351688070893
• UDI-Public: 00351688070893
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: 11/12/2024
• Device Model Number: 402515
• Device Catalogue Number: 402515
• Device Lot Number: 3912789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• 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: 04/14/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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