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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ SYRINGE PISTON SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 302633
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2022
Event Type  malfunction  
Event Description
It was reported that the bd solomed¿ syringe was cracked and leaked while aspirating the product. The following information was provided by the initial reporter, translated from portuguese: it was received through service 202209774, the market complaint where the customer reports that, when aspirating the product, he found that the syringe had a crack. As a result, the liquid leaked, making it impossible to use the product.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD SOLOMED¿ SYRINGE
Type of DevicePISTON 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 Key15280202
MDR Text Key303226529
Report Number3003916417-2022-00162
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
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 08/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number302633
Device Lot Number9343672
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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