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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE, 12.7MM 3/10ML 1/2" 30G SYRINGE, PISTON

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BECTON DICKINSON BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE, 12.7MM 3/10ML 1/2" 30G SYRINGE, PISTON Back to Search Results
Model Number 08290
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
I took the protective sheathe off my becton dickenson ( bd) insulin syringe (with bd ultra-fine needle 127mm 3/10ml 1/2' x 30g) and found the needle bent at 40 degrees of vertical. This is a common occurrence with this model syringe. When i open their syringes, i find 12% to be off vertical to this degree. Many others are bent, but to a lesser degree. I have communicated with bd by phone and snail mail regarding this issue with no promise to 'fix' this manufacturing problem. They have sent me a two replacement boxes distributed by my local pharmacy, which is (b)(6) at (b)(6). This is a problem i been facing for the past 5 years or more. I have to bend the needle back to vertical using the rubber cap on the bottle of insulin. Bd have demonstrated no interested in correcting it manufacturing process. The 'test date' asked for below is every 2-3 days a week. I make no error when unsheathing, a process i have practiced since the launch of bd's disposable syringe in 1961. I been type 1 diabetic since (b)(6) of 1958. Fda safety report id # (b)(4).
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE, 12.7MM 3/10ML 1/2" 30G
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12294039
MDR Text Key266194193
Report NumberMW5103081
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 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number08290
Device Lot Number1018138 A
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

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