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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
Catalog Number 328509
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date : unknown. Investigation summary : exec summary - samples were received and an investigation was performed. This is the 2nd complaint for needle hub separates on this lot number. A review of the manufacturing records was performed and one non-conformances was 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) 0. 5ml insulin syringes in open polybags from lot# 9176542. The consumer reported that needle hub separated and needle shield is difficult to remove. Both returned syringes were examined and it was observed that both exhibited a detached needle hub/shield assembly. No damage to the barrel tip of either syringe was observed. Manufacturing (holdrege) will be notified of the observed 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 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 8mm hub separated from the device. The following information was provided by the initial reporter : the consumer reported the needle hub separated and the needle shield was difficult to remove. 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 Key12409401
MDR Text Key269627629
Report Number1920898-2021-00950
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 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328509
Device Lot Number9176542
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2019
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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