MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC; SAFETY SYRINGE WITH NEEDLE

Catalog Number 10161

Device Problems Leak/Splash (1354); Fail-Safe Problem (2936)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes this safety syringe.Retractable technologies manufacturers the syringe that was included in the kit.We have notified (b)(4) for awareness.

Event Description

The customer states there was a malfunction with the syringe and the patient did not receive the full dose of vaccine due to some of it ran down patient arm.No information was received regarding any serious injury as a result of this product malfunction.This complaint was initially reported to pfizer and pfizer forwarded to mckesson.

• Type of Device: SAFETY SYRINGE WITH NEEDLE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC; 511 lobo ln; little elm TX 75068
• Manufacturer (Section G): MCKESSON MEDICAL SURGICAL, INC; 1125 sycamore road; manteno IL 60950
• Manufacturer Contact: jo silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 12870222
• MDR Text Key: 283952106
• Report Number: 3017368639-2021-00188
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10161
• Device Lot Number: G210406
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other