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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 10ML LL; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO SYRINGE 10ML LL; PISTON SYRINGE Back to Search Results
Model Number 309604
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
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 six syringe 10ml ll had a damaged barrels.The following information was provided by the initial reporter: "6 syringes from this lot had small pin hole in barrel, all in the same spot.".
 
Event Description
It was reported six syringe 10ml ll had a damaged barrels.The following information was provided by the initial reporter: "6 syringes from this lot had small pin hole in barrel, all in the same spot".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-28.Investigation summary: three 10ml syringes received for investigation, samples were visually inspected.On the first syringe there was a hole observed between lines 4 and 5.The second syringe, a small crack is observed between lines 3 and 4.No defects or issues observed on the third syringe.Functional testing was performed, leakage was observed on the first and second sample.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
 
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Brand Name
SYRINGE 10ML LL
Type of Device
PISTON 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12380411
MDR Text Key269605955
Report Number9614033-2021-00100
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096047
UDI-Public30382903096047
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 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309604
Device Catalogue Number309604
Device Lot Number1013903
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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