• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA PISTON SYRINGE Back to Search Results
Model Number 329420
Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that a syringe 1. 0ml 28ga 1/2in bls 500 sus ca had difficult plunger movement during use. The following was reported by the initial reoprter: "it was reported that plunger rod is difficult to move and veins are blowing up. Verbatim: thanks for getting back to me. Many of your syringes have done that to me, where the plunger gets stuck (i think they're made too small so they stick). I've blown many veins due to this problem and yes, i also realize that iv drug use is also a high risk problem but i do know that if it weren't for your syringes, many of my veins would not have blown (up with air i think?). The product number is 329420. Lot #0262090. Information from email copied and pasted below:email received¿2021-04-01 09:20:10sent: wednesday, march 31, 2021 10:33 pm"this is now the 2nd time i've complained. You guys sell to exchange works programs. I got my needles/syringes from them but it says becton dickinson on the box. I just want to complain because many times i've used them, they get stuck and very hard to press!!! because of that, i've ruined veins!! if they had of worked properly, my veins would be fine, not blown up!! but because many of them are hard to press and get stuck, then when i finally get it to "press", the whole "profanity" vein blows up (with air, i'm presuming!). You guys and your lack of quality control are causing many drug users veins to blow up!! i guess all you care about is money, so you sell them to the exchange programs, who are there to stop aids (and other diseases) to stop spreading. But, i assure you, that there are probably many other people like me who get "stuck" needles that when finally pressed (or should i say, when they finally work properly!), the whole "profanity" vein blows up. You think aids and other diseases are dangerous? well, so are your needles!!"".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11735994
MDR Text Key251227617
Report Number1920898-2021-00477
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number329420
Device Catalogue Number329420
Device Lot Number0262090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-