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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE Back to Search Results
Model Number 928856
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event or Problem Description
It was reported that the syringe 1.0ml 31ga 8mm 10bag 500 pl/wg experienced the cannula breaking off.The following information was provided by the initial reporter: consumer reported that the needle broke off of the syringe while he was trying to insert it into the vial.
 
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Brand Name
SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
Common Device Name
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12229950
Report Number1920898-2021-00814
Device Sequence Number3357420
Product Code FMF
UDI-Device Identifier00311917048130
UDI-Public00311917048130
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K170386
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number928856
Device Catalogue Number928856
Device Lot Number1087652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/28/2021
Initial Report FDA Received Date07/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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