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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE Back to Search Results
Model Number 324910
Device Problem Volume Accuracy Problem (1675)
Patient Problem Insufficient Information (4580)
Event Date 10/25/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0167709; medical device expiration date: 2025-06-30; device manufacture date: 2020-06-15. Medical device lot #: 0189393; medical device expiration date: 2025-07-31; device manufacture date: 2020-07-07. Medical device lot #: 1016653; medical device expiration date: 2026-01-31; device manufacture date: 2021-01-16. Investigation summary: samples were received and an investigation was performed. This is the 1st complaint for the reported lot numbers. A review of the manufacturing records was performed and four non-conformances were raised in association with this type of event for this lot. Bd was not able to duplicate or confirm the indicated issue hence the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. Investigation conclusion: a complaint history check was performed and this is the 1st related complaint for scale misaligned on lot # 0167709. A review of the device history record was completed for batch # 0167709 all inspections were performed per the applicable operations qc specifications. There were three (3) notifications [200896025, 200895892, 200895293] noted that did not pertain to the complaint. There was one (1) notification [200895854] noted for partial missing scale line. There was one (1) notification [200896056] noted for scratched print. There were two (2) notifications [200894747, 200894674] noted for missing print. A review of the device history record was completed for batch # 1016653 all inspections were performed per the applicable operations qc specifications. There was one (1) notification [200931339] noted for missing numbers and scale line a complaint history check was performed and this is the 3rd related complaint for scale misaligned on lot #0189393. Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause cannot be determined at this time as the issue is unconfirmed. Based on the above, no additional investigation and no capa/sa is required at this time.
 
Event Description
It was reported that 690 bd insulin syringe with bd ultra-fine¿ needles experienced scale marking issues. The following information was provided by the initial reporter: the very first scale mark is way lower than it should be.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
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 Key12856724
MDR Text Key281518306
Report Number1920898-2021-01222
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249107
UDI-Public00382903249107
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number324910
Device Catalogue Number324910
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
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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