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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM Back to Search Results
Catalog Number 320469
Device Problems Delivered as Unsterile Product (1421); Defective Device (2588)
Patient Problem Needle Stick/Puncture (2462)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that syringe 1. 0ml 30ga 8mm experienced a case of a damaged product that's still considered operable, and a case of the product not being sterile. The following information was provided by the initial reporter: material no. 320469, batch no. 0301514. I was opening a bag of bd insulin syringes (1ml, 8mm, 30g) and got a pretty unexpected poke in my left thumb. After opening the bag it was apparent that only 9 of the 10 had caps on the needles. One was missing and not in the bag at all. The plunger and end cap were as they should be like the rest but the cap was missing and it got stuck in my thumb while i was handling the bag. I definitely hope that these are sterile. I like the functionality of your syringes more than other brands but this was unpleasant.
 
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Brand NameSYRINGE 1.0ML 30GA 8MM
Type of DeviceSYRINGE
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 Key11767815
MDR Text Key248753230
Report Number1920898-2021-00510
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320469
Device Lot Number0301514
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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