MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT®; 25G X 1" SAFETY SYRINGE WITH NEEDLE

Model Number 10161

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Reporter called about pfizer-biontech covid-19 vaccine for the orange cap presentation.One of his vaccinators vaccinated a patient and some of the dose leaked out.He said that he isn't sure but it might have been a problem with the needle.He said that he is not sure how much the patient got, but he thinks that the patient received less than half of the recommended dose.

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 the lot number.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 the lot number.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

Reporter called about pfizer-biontech covid-19 vaccine for the orange cap presentation.One of his vaccinators vaccinated a patient and some of the dose leaked out.He said that he isn't sure but it might have been a problem with the needle.He said that he is not sure how much the patient got, but he thinks that the patient received less than half of the recommended dose.

• Brand Name: VANISHPOINT®
• Type of Device: 25G X 1" SAFETY SYRINGE WITH NEEDLE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; little elm TX 75068
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 13051228
• MDR Text Key: 284516387
• Report Number: 3017368639-2021-00192
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K980069
• 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 Operator: Health Professional
• Device Model Number: 10161
• Device Catalogue Number: 10161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• 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