MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT®; 1ML SYRINGE

Model Number	10161
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that include this syringe component.The manufacturer's lot number was confirmed as a lot number that has been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(6) and (b)(6) for awareness.
Event or Problem Description
Customer reported that the vanish point syringe is faulty.While the nurse was pushing down on the plunger of the syringe, all of the contents leaked out of the sides of the syringe and landed onto the patient's arm.

• Brand Name: VANISHPOINT®
• Common Device Name: 1ML SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; 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: 13670962
• Report Number: 3017368639-2022-00008
• Device Sequence Number: 20439996
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/02/2022

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 Expiration Date: 07/28/2026
• Device Model Number: 10161
• Device Catalogue Number: KC-10161
• Device Lot Number: G210841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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