MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC VANISHPOINT; 1ML 25G X 1" VANISHPOINT® SYRINGE

Model Number	10161
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported receiving two faulty vanish point syringes from the ancillary kits.The fist malfunction was when one of the needles would not retract easily.The second malfunction occurred when the needle retracted before the vaccine entered the patient, and the vaccine squirted all over the father's leg and patient's leg.
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the device from the manufacturer identified.The item ref # and lot # reported and identified in section d have been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(6) and (b)(6) for awareness.

• Brand Name: VANISHPOINT
• Common Device Name: 1ML 25G X 1" VANISHPOINT® 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 silverth ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 15152599
• Report Number: 3017368639-2022-00026
• Device Sequence Number: 17451622
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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
• Device Lot Number: G210841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/02/2022
• 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