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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK SYRINGE PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 301031
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: a device history record review was completed by our quality engineer team for provided material number 301031 and lot number 1116962. The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification. As a sample was not returned, a thorough sample investigation could not be completed. Based on the investigation results, an exact cause for this incident could not be identified. Further action has not been determined necessary at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 4550 bd luer-lok¿ syringes were missing the oz scale markings on them. The following information was provided by the initial reporter: "this syringe should have the oz marking. We did find out that we have been receiving without this marking since 2018. Unfortunately, we did not caught it. ".
 
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Brand NameBD LUER-LOK SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12407333
MDR Text Key270638791
Report Number1911916-2021-00907
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,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 Other
Device Catalogue Number301031
Device Lot Number1116962
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 Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2021
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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