MAUDE Adverse Event Report: UNKNOWN; SAFETY SYRINGE WITH NEEDLE

Lot Number UNKNOWN

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

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 (b)(4) a 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.

Event Description

Unknown supplier while preparing the pfizer vials noticed a black particle inside the solution; similar to a speck of black pepper.After thorough investigation, the customer came to the conclusion that upon insertion of the five(cc) dilution needle this was causing a piece of the rubber pfizer stopper to break off into the medication.

• Type of Device: SAFETY SYRINGE WITH NEEDLE
• Manufacturer (Section D): UNKNOWN
• Manufacturer (Section G): MCKESSON MEDICAL SURGICAL, INC.; 1125 sycamore road; manteno IL 60950
• Manufacturer Contact: michael morzuch ; 9954 mayland drive; richmond, VA 23233 ; 8044861404
• MDR Report Key: 12292933
• MDR Text Key: 267359724
• Report Number: 3017368639-2021-00127
• 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• 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