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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 302558
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
"there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #:7137557, expiration date: 04/30/2022, manufacture date: 07/04/2017. Medical device lot #: 7137559, expiration date: 04/30/2022, manufacture date: 07/07/201. 7 medical device lot #: unknown, expiration date: unknown, manufacture date: unknown. Medical device lot #: 8016550, expiration date: 12/31/2022, manufacture date: 02/27/2018. Initial reporter facility name: (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 nursing staff used the bd plastipak¿ syringe to permeabilize a high flow catheter. Upon return in the form of a flush, the blood flows out of a lateral crack in the syringe causing a splash towards the nursing staff, the hemodialysis machine, the patient and the wall. Exposure of blood splashed to the nursing staff. The boxes belonging to this lot were removed from storage and will not be used in the hospital. No medical intervention or serious injury reported.
 
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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 Key7485033
MDR Text Key107476042
Report Number9614033-2018-00020
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 foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number302558
Device Lot Number7230995
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2017
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: 05/03/2018 Patient Sequence Number: 1
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