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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Model Number 309658
Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Manufacturer Narrative
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 3ml bd plastipak¿ syringe luer-lok¿ tip experienced device damage while still considered operable. The following information was provided by the initial reporter: the nurses noted a defect in the rubber of the piston. Indeed, the latter seems to hang to the wall in an abnormal way. The plunger seems to stick to the wall in an abnormal way, thus causing a possible misreading of the volume taken. Current condition of the patient : no clinical consequences.
 
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Brand Name3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12305247
MDR Text Key266006493
Report Number1213809-2021-00556
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309658
Device Catalogue Number309658
Device Lot Number0297731
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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