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U.S. Department of Health and Human Services

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

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE LUER-LOK TIP PISTON SYRINGE Back to Search Results
Model Number 309653
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 05/14/2020
Event Type  Malfunction  
Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).

 
Event Description

It was reported that the shipping boxes of bd syringes with the luer-lok¿ tip had the volume listed as "50 ml" instead of "60 ml". This was noticed prior to use. The following information was provided by the initial reporter: "all stickers on the shipping boxes have the correct art. Number, however on 5 boxes out of 6 the volume of the syringes is stated as 50 ml instead of 60 ml. The real volume corresponds to the sticker. Only 1 box arrived with the correct sticker and volume of syringes. ".

 
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Brand NameBD SYRINGE LUER-LOK TIP
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10216167
MDR Text Key199913776
Report Number1911916-2020-00589
Device Sequence Number1
Product Code FMF
Combination Product (Y/N)N
Reporter Country CodeRS
PMA/PMN NumberK980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number309653
Device Catalogue Number309653
Device LOT Number9120907
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 Received05/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/30/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
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