MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT; SAFETY NEEDLE, 1 ML 25 GAUGE X 1"

Model Number	10161
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that immediately after removing a retractable technologies vanishpoint syringe from its wrapper, they saw liquid contained inside of the barrel of the syringe.The syringe was reported as a tuberculin syringe with needle, vanishpoint® 1 ml 25 gauge 1 inch regular wall retractable safety needle.Manufacturer model# 10161, lot # g210954.Additional product information is contained in this report.
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 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: SAFETY NEEDLE, 1 ML 25 GAUGE X 1"
• 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: 15651366
• Report Number: 3017368639-2022-00028
• Device Sequence Number: 17702492
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 10/21/2022

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: 08/23/2026
• Device Model Number: 10161
• Device Catalogue Number: 10161
• Device Lot Number: G210954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/21/2022
• 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