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

Model Number	10161
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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®
• Common Device Name: 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
• Report Number: 3017368639-2021-00192
• Device Sequence Number: 4646512
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K980069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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 Model Number: 10161
• Device Catalogue Number: 10161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown