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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE 3ML S/T 40MM 8DMM NBS; PISTON SYRINGE
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BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE 3ML S/T 40MM 8DMM NBS; PISTON SYRINGE Back to Search Results
Catalog Number 990597
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd syringe 3ml s/t 40mm 8dmm nbs, the device experienced leakage, and molding defect short shots on the barrel.The following information was provided by the initial reporter.The customer stated: the 3 ml syringes described below presented leaks, in addition, after inspection of the other units they had, they found that several of these, being sealed, were broken.They indicate that this situation has harmed them, on the one hand, giving a bad image to their clients and on the other hand, losing doses of vaccines due to leaks.Blood leaking.There were no injuries or need for medical intervention.Indicates that there was blood exposure (unknown if the exposure was to profesional).
 
Event Description
It was reported when using the bd syringe 3ml s/t 40mm 8dmm nbs, the device experienced leakage, and molding defect short shots on the barrel.The following information was provided by the initial reporter.The customer stated: the 3 ml syringes described below presented leaks, in addition, after inspection of the other units they had, they found that several of these, being sealed, were broken.They indicate that this situation has harmed them, on the one hand, giving a bad image to their clients and on the other hand, losing doses of vaccines due to leaks.Blood leaking.There were no injuries or need for medical intervention.Indicates that there was blood exposure (unknown if the exposure was to professional).
 
Manufacturer Narrative
H6: investigation summary: photos received for investigation, upon visual inspection it is possible to observe the presence of foreign matter in the syringe, and barrel cracked.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.Possible root cause for barrel cracked, and leakage effect is associated with failure of the barrels input disk synchronizer.Corrective action was taken, adjusting the disk timing.Based on the quality team's investigation, and without physical samples, we are not able to identify a root cause related to our manufacturing process at this time for foreign matter.H3 other text : see h10.
 
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Brand Name
BD SYRINGE 3ML S/T 40MM 8DMM NBS
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer (Section G)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12544186
MDR Text Key273879127
Report Number3003916417-2021-00309
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCI
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 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990597
Device Lot Number0169967
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2020
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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