MAUDE Adverse Event Report: UNKNOWN; SAFETY SYRINGE

Model Number UNKNOWN

Device Problem Defective Component (2292)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes a safety syringe with needle.However, the complaint reporter was unable to provide either the product manufacturer information nor any product identification details.We have notified (b)(6) and (b)(6) for awareness.

Event Description

Reporter called to advise of a nurse's finger becoming stuck due to a malfunction of the syringe's safety glide.Reporter was not able to identify the kit item # that contained the malfunctioning syringe.

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes a safety syringe with needle.However, the complaint reporter was unable to provide either the product manufacturer information nor any product identification details.We have notified (b)(6) and (b)(6) for awareness.

Event Description

Reporter called to advise of a nurse's finger becoming stuck due to a malfunction of the syringe's safety glide.Reporter was not able to identify the kit item # that contained the malfunctioning syringe.

• Type of Device: SAFETY SYRINGE
• Manufacturer (Section D): UNKNOWN
• 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: 13239508
• MDR Text Key: 285992295
• Report Number: 3017368639-2022-00002
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2022
• 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