MAUDE Adverse Event Report: MCKESSON MEDICAL SURGICAL, INC.; SAFETY SYRINGE WITH NEEDLE

Catalog Number UNKNOWN

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/04/2021

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 both (b)(4) 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 five occurrences of foreign matter without any product identification.This is three of five mdrs filed.

Event Description

The customer reported that 5 syringes had black particulate matter.Product identification was not provided by the customer.The impacted product was confirmed to have been destroyed.No information was received regarding any serious injury as a result of this product report.

• Type of Device: SAFETY SYRINGE WITH NEEDLE
• 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: 12293271
• MDR Text Key: 267340690
• Report Number: 3017368639-2021-00113
• 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: 07/28/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• 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