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

Lot Number G201114

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical surgical is the assembler of the ancillary convenience kit to support the u.S.Government's covid-19 vaccination program.We previously reported this event to cdc and barda but recognize due to a retrospective review that this event should have also been reported as an mdr to fda.As part of our continuous improvement goals we are providing this mdr for review.This customer reported seven occurrences of foreign matter with limited product identification (lot number only).This is five of seven mdrs filed.

Event Description

The customer reported that numerous syringes contain an unexplained fluid, visible in some of the syringes before use.The issue was identified across 7 different lots.This mdr is specific for lot g201114.No information was received regarding any serious injury as a result of this product report.

• 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: 12293287
• MDR Text Key: 267349403
• Report Number: 3017368639-2021-00121
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: G201114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2021
• 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