MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT; SAFETY SYRINGE

Model Number	10161
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that use a component from the manufacturer listed in part d of this report.However, due to the limited information provided and able to be obtained via follow-up, it is not conclusive whether the product for which complaint was reported came from a convenience kit supplied by mckesson medical-surgical, inc.We have notified (b)(6) and (b)(6) for awareness.
Event or Problem Description
Caller reported vanishpoint 1ml 25g x 1 inch syringe leaked while administering to 6 year old child.Healthcare provider was unsure if patient needed to be vaccinated again.We contacted the reporter by phone on 07-jan-2022 and 25-jan-2022 to obtain further details.The manufacturer's name was provided, but the lot number could not be provided by the reporter.

• Brand Name: VANISHPOINT
• Common Device Name: SAFETY SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo lane; little elm TX 75068
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 13453535
• Report Number: 3017368639-2022-00005
• Device Sequence Number: 20055318
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 02/02/2022

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/04/2022
• 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