MAUDE Adverse Event Report: UNKNOWN UNKNOWN; SAFETY SYRINGE

Catalog Number	UNKNOWN
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SAFETY SYRINGE
• Manufacturer (Section D): UNKNOWN; unknown; unknown
• MDR Report Key: 11869447
• Report Number: 3017368639-2021-00043
• Device Sequence Number: 15867257
• Product Code: MEG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other