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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM PISTON SYRINGE Back to Search Results
Catalog Number 326638
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: exec summary: samples were received and an investigation was performed. A review of the complaint lot history check was performed and this is the 7th related complaint for needle hub separates on this lot #. No non-conformance's were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications. 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 (1) 3/10cc, 8mm, 30g syringe in an open poly bag from lot # 0286309. Customer states that the hub separation is occurring before use. The returned syringe was examined and exhibited the hub-needle/shield assembly separated from the barrel. Manufacturing ((b)(4)) will be notified of this issue. 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 conformance's 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. 3ml 30ga 8mm hub separated from the device. The following information was provided by the initial reporter: the user reported that the hub separation occurred before use.
 
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Brand NameBD SYRINGE 0.3ML 30GA 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 Key12520103
MDR Text Key272941228
Report Number1920898-2021-01013
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 consumer,distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326638
Device Lot Number0286309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2020
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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