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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 20X1-1/2 RB PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 20X1-1/2 RB PISTON SYRINGE Back to Search Results
Model Number 309635
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 07/08/2020
Event Type  Injury  
Manufacturer Narrative
Date of birth: only the patient's age was provided therefore a default date of birth has been listed. 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 an unspecified number of syringes 5 ml ll w/ndl 20x1-1/2 rb experienced leakage and exposure to mucosal membrane during use. The following information was provided by the initial reporter: material no. :309635, batch no. :9155519. There was a crack in the barrel of the syringe that caused the medication oxytocin which is considered hazardous to shoot out into the employee's eye. The employee was observed in the er and eyes were flushed with water and has had no other issues or tests.
 
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Brand NameSYRINGE 5ML LL W/NDL 20X1-1/2 RB
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10348358
MDR Text Key202540669
Report Number1213809-2020-00502
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309635
Device Catalogue Number309635
Device Lot Number9155519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/04/2019
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: 07/30/2020 Patient Sequence Number: 1
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