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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date : unknown. Initial reporter phone# : unknown. Initial reporter zip code : unknown. A device evaluation is pending but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date : unknown.
 
Event Description
It was reported that 1 bd syringe 0. 3ml 29ga 1/2in hub separated. The following information was provided by the initial reporter : the customer reported that when removing the shield, the needle with the shied was separated from the barrel.
 
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Brand NameSYRINGE 0.3ML 29GA 1/2IN
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 Key12125787
MDR Text Key263387931
Report Number1920898-2021-00724
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326631
Device Lot NumberUNKNOWN
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 Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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