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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 5ML S/SU; PISTON SYRINGE
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BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 5ML S/SU; PISTON SYRINGE Back to Search Results
Catalog Number 990175
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Event Description
It was reported when using the bd syringe plastipak 5ml s/su, the device experienced scale marking issues.The following information was provided by the initial reporter.The customer stated: when opening the syringe, it was observed that the volume recording was not made by the manufacturer, and it is not possible to quantify the volume to be aspirated.
 
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.
 
Manufacturer Narrative
H.6.Investigation: batch history analysis (dhr), maintenance records and quality notifications were verified.A maintenance order was observed that could potentially be related to the incident (603392329 - marking with insufficient ink flow), however, as photos / samples were not made available by the customer for evaluation, it is not possible to carry out an investigation and determine the root cause for the incident, therefore it is not possible to confirm the claim.H3 other text : see h.10.
 
Event Description
It was reported when using the bd syringe plastipak 5ml s/su, the device experienced scale marking issues.The following information was provided by the initial reporter.The customer stated: when opening the syringe, it was observed that the volume recording was not made by the manufacturer, and it is not possible to quantify the volume to be aspirated.
 
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Brand Name
BD SYRINGE PLASTIPAK 5ML S/SU
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13238128
MDR Text Key289262230
Report Number3003916417-2021-00400
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K182589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990175
Device Lot Number1048022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age24 DA
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