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

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

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.The customer did not provide any product identification.We have notified (b)(6) for awareness.

Event Description

The customer asked for guidelines for loose syringe resulting in partial dose given to patient.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 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: 12606777
• MDR Text Key: 277394231
• Report Number: 3017368639-2021-00177
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/07/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/11/2021
• 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