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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 PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE Back to Search Results
Model Number 928857
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary : exec summary - samples were received and an investigation was performed. A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot. Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time. Samples returned - customer returned (2) loose 0. 5ml insulin syringes. Consumer reported that the needle hub separated and stayed in the shield. The returned sample was examined, and it was observed that the cannula hub / shield assembly was separated from the barrel. No damage to the barrel tip was observed. Capa/sa - capa (b)(4) has been opened to address the issue. Dhr review - a review of the device history record was completed for batch# 0006836. All inspections and challenges were performed per the applicable operations qc specifications. There were zero (0) notifications noted that pertained to the complaint.
 
Event Description
It was reported that 1 bd syringe 0. 5ml 31ga 8mm hub separated. The following information was provided by the initial reporter : the consumer reported that the needle hub separated and stayed in the shield. Date of event: unknown. Samples: available.
 
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Brand NameSYRINGE 0.5ML 31GA 8MM
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 Key11964908
MDR Text Key255142445
Report Number1920898-2021-00650
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 05/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number928857
Device Catalogue Number928857
Device Lot Number0006836
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 Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2020
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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