MAUDE Adverse Event Report: BECTON DICKINSON BD INSULIN SYRINGE; SYRINGE, PISTON

Lot Number 3219230

Patient Problems Malaise (2359); Taste Disorder (4422)

Event Date 01/24/2024

Event Type  Death  

Event Description

Husband picked up new tirzepatide prescription from compounding pharmacy (b)(6) on (b)(6) 2024.At 6pm gave himself first dose of the medication.Wife watched him do it because he's nearsighted and wanted to ensure correct dose.He injected into thigh.He stated it gave "funny taste" in mouth after taking.Wife reported strange as she is nurse practitioner, and wonders if there was issue with syringe.He usually gets up around 5:30am to get granddaughter and he did not get up as usual.He took son to school around 6:40am.Told son he didn't feel well.Did not report this to wife.Wife left for work at 7:30am.Husband laid down after and never got up.Wife received call around 1:00pm in afternoon that he had not shown up to work.911 called and husband found deceased at home.Contact information for the pharmacy: (b)(6).Reason for use: obesity.

• Brand Name: BD INSULIN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 18685786
• MDR Text Key: 335247501
• Report Number: MW5151338
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 3219230
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: TIRZEPATIDE 20MG/ML (VIAL) (1ML)
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White