MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES VANISHPOINT; 1ML SYRINGE / NEEDLE COMBO

Model Number	10161
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the device from the manufacturer identified in section d.The item ref # and lot # reported and identified has been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(4) for awareness.
Event or Problem Description
Complaint reporter indicated the following via e-mail on 15-march-2022: "the 1ml vanishpoint syringe/needle combo's don't retract reliably and with children, it's not safe to run the risk of not having it retract and accidently poking a child/caregiver or the vaccine administrator." six (6) lot numbers of the 1ml vanishpoint syringe/needle combo were identified by the reporting site as defective.The event dates for the reported lot numbers are unknown.

• Brand Name: VANISHPOINT
• Common Device Name: 1ML SYRINGE / NEEDLE COMBO
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES; 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: 14113530
• Report Number: 3017368639-2022-00013
• Device Sequence Number: 4612918
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 08/28/2026
• Device Model Number: 10161
• Device Catalogue Number: 10161
• Device Lot Number: G211116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/14/2022
• 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