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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM 10BAG 500CS PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM 10BAG 500CS PISTON SYRINGE Back to Search Results
Model Number 324912
Device Problem Defective Device (2588)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
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 no non-conformances were 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. Based on the above, no additional investigation and no capa/sa is required at this time.
 
Event Description
It was reported that syringe 1. 0ml 31ga 6mm 10bag 500cs scale markings were misaligned. The following information was provided by the initial reporter: it was reported that insulin syringes has the needle shield off the syringe in bag. Caused a clean needle stick to employee that was treated with minor first aid. Verbatim: minor first aid was given to our employee. This was the first incident reporting of this employee. We have had four bags with insulin syringes that had at least one cap off in the plastic bag. (these are in our sharps container. ) we have come across some insulin syringes that the caps are off in the plastic bag exposing the needle. This is a safety issue as we had an employee puncture his thumb which is then a biohazard.
 
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Brand NameSYRINGE 1.0ML 31GA 6MM 10BAG 500CS
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 Key12537712
MDR Text Key273569131
Report Number1920898-2021-01018
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number324912
Device Catalogue Number324912
Device Lot Number0252919
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 Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2020
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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