MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE TUBERCU 27GX1/2 1CC; SYRINGE, PISTON

Lot Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2021

Event Type  Death  

Event Description

Patient husband reported that patient deceased on (b)(6) 2021.

• Brand Name: SYRINGE TUBERCU 27GX1/2 1CC
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY ; 1 becton dr ; franklin lakes NJ 07417
• MDR Report Key: 12496091
• MDR Text Key: 272439185
• Report Number: MW5104053
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290309623
• UDI-Public: 08290309623
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR