MAUDE Adverse Event Report: UNKNOWN UNKNOWN; SAFETY SYRINGE

Model Number UNKNOWN

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

The caller from the (b)(6) pharmacy, reported that they are giving booster shot to patient with a faulty syringe.Only 0.1ml was injected into the arms and the other amount leaked.

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes this safety syringe.The reporter did not provide any product identification details.We have notified (b)(6) for awareness.

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes this safety syringe.The reporter did not provide any product identification details.We have notified asprsnsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov for awareness.This submittal is in follow-up to concerns that the initial submittal on 21-dec-2021 was not packaged correctly and did not contain all of the necessary files.As a follow-up, this report is being submitted again.

Event Description

The caller from the walgreens pharmacy, reported that they are giving booster shot to patient with a faulty syringe.Only 0.1ml was injected into the arms and the other amount leaked.

• Brand Name: UNKNOWN
• Type of Device: SAFETY SYRINGE
• Manufacturer (Section D): UNKNOWN
• Manufacturer Contact: 9954 mayland drive; richmond, VA 23233
• MDR Report Key: 13051302
• MDR Text Key: 284514860
• Report Number: 3017368639-2021-00194
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REPORTER UNABLE TO PROVIDE MODEL # OR LOT #.; REPORTER UNABLE TO PROVIDE MODEL # OR LOT #.
• Patient Outcome(s): Other