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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ SYRINGE; PISTON SYRINGE

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BECTON DICKINSON, S.A. BD¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 301942
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
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 500 bd¿ syringes had plunger leakage issues.The following information was provided by the initial reporter, translated from chinese to english: the distributor reported that the syringe leaked when the liquid was drawn after opening the package and the quantity is temporarily uncertain.
 
Manufacturer Narrative
Investigation summary: a device history record review was completed for provided material number 301942 and lot number 2107191.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, a video sample was returned for evaluation by our quality engineer team.Through examination of the video, the reported defect could be confirmed.Based on the provided feedback and the video sample, we have concluded that this type of damage may result as a consequence of damage to the plunger lip component.This type of damage can be produced during the handling of the product through the manufacturing process or within the plunger assembly machine.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.
 
Event Description
It was reported that 500 bd¿ syringes had plunger leakage issues.The following information was provided by the initial reporter, translated from chinese to english: the distributor reported that the syringe leaked when the liquid was drawn after opening the package and the quantity is temporarily uncertain.
 
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Brand Name
BD¿ SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15160920
MDR Text Key297249645
Report Number3002682307-2022-00203
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301942
Device Lot Number2107191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received08/03/2022
Supplement Dates Manufacturer Received09/09/2022
Supplement Dates FDA Received09/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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