MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC VANISHPOINT; SYRINGE/NDL, VANISH POINT 1CC 25GX1"

Catalog Number 10161

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical surgical is the assembler of the (b)(4), pediatric ancillary 450 dose master convenience kit (lot # 210517-mi1) on behalf of the sns that includes this safety syringe.Retractable technologies is the manufacturer of the syringe.We have notified asprsnsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov who would have passed along this information to retractable technologies, the manufacturer of the syringe so they may conduct a device evaluation as warranted.

Event Description

The customer reported that they had a leaky syringe when administering a pfizer covid vaccine.No information was received regarding any serious injury as a result of this product malfunction.

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE/NDL, VANISH POINT 1CC 25GX1"
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC; 511 lobo ln; little elm TX 75068
• Manufacturer (Section G): MCKESSON MEDICAL SURGICAL, INC.; 1125 sycamore road; manteno IL 60950
• Manufacturer Contact: jo silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 12323778
• MDR Text Key: 268205749
• Report Number: 3017368639-2021-00166
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10161
• Device Lot Number: G210403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other