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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50 PISTON SYRINGE

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BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50 PISTON SYRINGE Back to Search Results
Catalog Number 303310
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that syringe 20ml ll s/c 50 was cracked and leaked. The following information was provided by the initial reporter: material no: (b)(4). Batch no: 0136387, 0098741.   it was reported that 3 syringes cracking down the right side of the syringe.   verbatim: report of 3 syringes cracking down the right side of the syringe. Sprayed tech in the face w/ venofor(?), he sought medical attn, initials jmm, week of dec 4th she has the syringes available to return.
 
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Brand NameSYRINGE 20ML LL S/C 50
Type of DevicePISTON SYRINGE
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
8015296192
MDR Report Key11159521
MDR Text Key230282318
Report Number9614033-2021-00005
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303310
Device Lot Number0098741
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 Received02/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2020
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: 01/13/2021 Patient Sequence Number: 1
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