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U.S. Department of Health and Human Services

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

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BD B-D INSULIN SYRINGE 1/2 ML, 8MM LENGTH, 31 GAUGE SYRINGE, PISTON Back to Search Results
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).
 
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Brand NameB-D INSULIN SYRINGE 1/2 ML, 8MM LENGTH, 31 GAUGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key12474893
MDR Text Key271694424
Report NumberMW5103926
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
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 Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0265850 C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
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