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

Catalog Number 10161

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit, on behalf of the sns, that includes this safety syringe.Retractable technologies manufactures the syringe that was included in the kit.Mckesson medical-surgical does not undertake any further manufacturing or relabeling of the syringe.We have notified (b)(6) who will pass along this information to retractable technologies, the manufacturer of the syringe so they many conduct a device evaluation as warranted.The customer reported twenty occurences of foreign matter.This is thirteen of twenty mdr's filed.

Event Description

The customer reported receiving vanishpoint needles with residue in the syringes.At least 20 syringes have been discarded thus far.This will be logged as 20 separate complaints.No information was received regarding any serious injury as a result of this product malfunction.

• Brand Name: VANISH POINT
• 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: 12323761
• MDR Text Key: 268100166
• Report Number: 3017368639-2021-00158
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2021

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: G210223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: No
• 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