MAUDE Adverse Event Report: UNKNOWN UNKNOWN; SAFETY SYRINGE

Catalog Number UNKNOWN

Device Problem Protective Measures Problem (3015)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/04/2021

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.Customer was unable to provide specifics for the kit or the syringe which prevented us from identifying the manufacturer of the syringe.Mckesson medical-surgical does not undertake any further manufacturing or relabeling of the syringes that are included in the convenience kits.We have notified asprsnsopscell@cdc.Gov.

Event Description

It was reported that the syringe malfunctioned.It was estimated that maybe about half of the covid vaccine was injected.There was spray back from the syringe contents and the patient's blood sprayed the nursed.No information was received regarding any serious consequence as a result of this product malfunction.

• Brand Name: UNKNOWN
• Type of Device: SAFETY SYRINGE
• Manufacturer (Section D): UNKNOWN; unknown; unknown
• Manufacturer (Section G): MCKESSON MEDICAL SURGICAL, INC.; 1125 sycamore road; manteno IL 60950
• Manufacturer Contact: jo silverrthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 11869447
• MDR Text Key: 255194210
• Report Number: 3017368639-2021-00043
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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: 05/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other