MAUDE Adverse Event Report: BD B-D INSULIN SYRINGE 1/2 ML, 8MM LENGTH, 31 GAUGE; SYRINGE, PISTON

Lot Number 0265850 C

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

Incorrect insulin dosing; b-d syringes (not all from same lot) have been not putting air into vial, no air bubbles, nor have they drawn out insulin from the vial.Vacuum within the vial was checked by me placing more air in with working syringe, and at the same time a check for too much air present in vial was ruled out by removing air with functional syringe.I have been insulin-dependent diabetic for decades and there have been a handful of the same occurrence only within the last two years (never 1975-2019).I first reported to b-d (b)(6) 2020 (quantity of 1 which was sent back in their metal tin hazmat).Reported to b-d with the samples sent and there has been no response, nor follow up.Syringes with this same problem found early 2021: the second round of reports and return of more than 1 syringe problem to b-d was on (b)(6) 2021.I sent back numerous and never heard a word.I am now sending this report to you, the government entity, in order to get some follow up.I have two syringes out of different packages of 10 packed into a box.Both are same lot number provided.Both again have the same problem described.I am keen on seeing because of how long in years i have been using, someone new using these may not notice and believe they are getting a proper dosage.I use 3 of these syringes per day, and one pen needle per day so you have a background on usage frequencies.Fda safety report id# (b)(4).

• Brand Name: B-D INSULIN SYRINGE 1/2 ML, 8MM LENGTH, 31 GAUGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 12474893
• MDR Text Key: 271694424
• Report Number: MW5103926
• Device Sequence Number: 2
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0265850 C
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR