MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 6MM; PISTON SYRINGE

Catalog Number 324911

Device Problem Failure to Deliver (2338)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 2 syringe 0.5ml 31ga 6mm had plunger movement difficulty.The following information was provided by the initial reporter:   the consumer reported that when injecting a syringe the plunger will not depress and allow for the flow of medication, the plunger stopped moving during injections and when pressed harder on the plunger rod that created pain and bleeding at injection site.Date of event : (b)(6) 2021 sample status: awaiting sample.

• Brand Name: SYRINGE 0.5ML 31GA 6MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12178205
• MDR Text Key: 262649984
• Report Number: 1920898-2021-00762
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324911
• Device Lot Number: 1004559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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