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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 6MM PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 6MM PISTON SYRINGE Back to Search Results
Catalog Number 324911
Device Problem Material Separation (1562)
Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The customer's address is unknown. New jersey (nj), usa has been used as a default. Investigation summary : exec summary - samples were received and an investigation was performed based only on the photos provided. This is the 1st related complaint for needle hub separates on the reported lot number. 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 - no physical sample device returned. Photos - three photos of a 0. 5ml bd insulin syringe were provided. The consumer reported owing to wrong needle assembly, experienced a needle stick. The photos were examined and it was observed that the needle hub and shield assembly was not fully seated on the barrel tip and the cannula was pierced through the shield. No damage to the barrel tip was observed in the photos where the hub assembly is detached from the barrel of the syringe. The exposed cannula could have led to a needle stick. Manufacturing (holdrege) will be notified of the observed issues. Capa/sa - capa (b)(4) has been opened to address this issue. Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
 
Event Description
It was reported that 1 bd syringe 0. 5ml 31ga 6mm hub separated from the device. The following information was provided by the initial reporter :   it was reported by the consumer that owing to a wrong needle assembly the consumer experienced a needle stick.
 
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Brand NameBD SYRINGE 0.5ML 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 Key12454513
MDR Text Key271063228
Report Number1920898-2021-00981
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 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324911
Device Lot Number8274826
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 Received08/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2018
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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