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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
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 the bd plastipak¿ syringe experienced leakage.The following information was provided by the initial reporter: leakage of a medicine by the plunger of a 60ml bd plastipak syringe.
 
Event Description
It was reported that the bd plastipak¿ syringe experienced leakage.The following information was provided by the initial reporter: leakage of a medicine by the plunger of a 60ml bd plastipak syringe.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-aug-2022.H6: investigation summary: one sample was provided to our quality team for investigation.The product was visually inspected, no damaged was identified in the barrel or other components that could have caused a leak and the stopper was verified to be properly assembled onto the plunger rod.A device history review was performed for the reported lot 2111017, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.H3 other text : see h10.
 
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Brand Name
BD PLASTIPAK¿ SYRINGES
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15317416
MDR Text Key301996160
Report Number3003152976-2022-00390
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/24/2022
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 Health Professional
Device Catalogue Number300865
Device Lot Number2111017
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2022
Initial Date FDA Received08/29/2022
Supplement Dates Manufacturer Received10/24/2022
Supplement Dates FDA Received11/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2021
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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