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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Catalog Number 309653
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter: address unavailable. Bd corporate address used. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that plunger rod is difficult to move with a bd 60ml syringe luer-lok¿ tip. The following information was provided by the initial reporter: consumer reported that the plunger rod is difficult to move, consumer uses luer lok item # 309653 for feeding and flushing feeding tube, feeds eight times a day with same syringe.
 
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Brand NameBD 60ML 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 Key8571056
MDR Text Key143978141
Report Number1911916-2019-00432
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 consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309653
Device Lot Number8220704
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2018
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: 05/01/2019 Patient Sequence Number: 1
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