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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN Back to Search Results
Catalog Number 328821
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that syringe 0. 5ml 31ga 8mm tw 10bag 500 twn was damaged. The following information was provided by the initial reporter: distorted barrel.
 
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Brand NameSYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN
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 Key11693329
MDR Text Key246290190
Report Number1920898-2021-00431
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328821
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
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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