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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE Back to Search Results
Catalog Number 324909
Device Problem Failure to Deliver (2338)
Patient Problem Hyperglycemia (1905)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter city and state : unknown, reported through (b)(6). Initial reporter zip code : unknown. Investigation summary: exec summary: no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined. A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot. Capa/sa: based on the above no additional investigation and no capa/sa are required at this time. Dhr review: a review of the device history record was completed for batch # 8037768 all inspections were performed per the applicable operations qc specifications.
 
Event Description
It was reported that 1 syringe 0. 3ml 31ga 6mm was unable or difficult to aspirate. The following information was provided by the initial reporter:   the consumer reported not being able to draw insulin.   date of event: (b)(6) 2021. Sample: no.
 
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Brand NameSYRINGE 0.3ML 31GA 6MM
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 Key12147732
MDR Text Key262447452
Report Number1920898-2021-00741
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324909
Device Lot Number8037768
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 Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2018
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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