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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGE

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BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGE Back to Search Results
Catalog Number 302562
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 the bd plastipak¿ syringes had air bubbles inside them. There was no report of exposure, injury, or medical intervention.
 
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Brand NameBD PLASTIPAK¿ SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7910111
MDR Text Key121863261
Report Number9614033-2018-00077
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
N/A
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,Followup,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302562
Device Lot Number7342618
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 Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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: 09/26/2018 Patient Sequence Number: 1
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