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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5ML 31GX6MM U-100 INSULIN SYRINGE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE 0.5ML 31GX6MM U-100 INSULIN SYRINGE PISTON SYRINGE Back to Search Results
Model Number 328520
Device Problems Volume Accuracy Problem (1675); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A review of the manufacturing records was performed, and one non-conformance was raised in association with this type of event for this lot. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Investigation conclusion: a complaint lot history check was performed on lot # 0013117 for scale marking defective (difficulty understanding scale). This is the 1st related complaint for scale marking defective (difficulty understanding scale) on lot # 0013117. A complaint lot history check was performed on lot # 0013117 for difficult/unable to operate (incorrect dose). This is the 1st related complaint for difficult/unable to operate (incorrect dose) on lot # 0013117. A review of the device history record was completed for batch# 0013117. All inspections and challenges were performed per the applicable operations qc specification. There was one (1) notification [200871302] noted for missing print. As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that 0. 5ml 31gx6mm u-100 insulin syringe experienced a case of scale marking issues, and under dosage. The following information was provided by the initial reporter: consumer/pet owner reported asking how to read the scale markings on syringe. He checked with the pharmacy first and was misinformed. Pet owner was told first line that is longer and darker than other scale lines, that is also the marker when plunger is pressed completely to the top, is the one unit line and not the zero line. Resulted in giving his dog 2 units instead of 3 as prescribed. Pet owner did not see instructions on the unit line measurements.
 
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Brand Name0.5ML 31GX6MM U-100 INSULIN SYRINGE
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 Key12298923
MDR Text Key265802211
Report Number1920898-2021-00880
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 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328520
Device Catalogue Number328520
Device Lot Number0013117
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 Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2020
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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