MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HYPODERMIC NEEDLE-PRO EDGE FIXED NEEDLE TB SYRINGE; SYRINGE, ANTISTICK

Model Number	4427-TB
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was almost impossible to draw up an entire dose of blood due to slowness of the product causing air bubbles.Device did not seem sharp after inserting into the heparin vial.Patients have been complaining that the needle hurts more than previous tuberculosis (tb) needles.No patient injury was reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the lot number provided was not valid.No root cause could be determined as the complaint could not be confirmed.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: HYPODERMIC NEEDLE-PRO EDGE FIXED NEEDLE TB SYRINGE
• Common Device Name: SYRINGE, ANTISTICK
• 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: 15462465
• Report Number: 3012307300-2022-20003
• Device Sequence Number: 7011414
• Product Code: MEG
• UDI-Device Identifier: 00351688064489
• UDI-Public: 00351688064489
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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 Model Number: 4427-TB
• Device Catalogue Number: 4427-TB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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