MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD SYR LUER-LOK 3ML #9657 DISP SYRINGE; SYRINGE, PISTON

Model Number 9657

Device Problem Use of Device Problem (1670)

Patient Problem Underdose (2542)

Event Date 07/09/2019

Event Type  No Answer Provided  

Event Description

Pt uses medication every 14 days and he missed his previous dose: twenty-eight days between injections instead of 14 days as prescribed.Did not experience any breakthrough bleeds.

• Brand Name: BD SYR LUER-LOK 3ML #9657 DISP SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 8842483
• MDR Text Key: 153134013
• Report Number: MW5088484
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290309657
• UDI-Public: 08290309657
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 22 YR