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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 1ML INSULIN S/SU PISTON SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 1ML INSULIN S/SU PISTON SYRINGE Back to Search Results
Catalog Number 990256
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
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 that 2 bd syringe plastipak 1ml insulin s/su had product damage and leakage issues. The following information was provided by the initial reporter : it was reported that during an intravitreal injection procedure in a patient the medication was lost because the syringe was damaged on the side with a cracked barrel resulting in leakage.
 
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Brand NameBD SYRINGE PLASTIPAK 1ML INSULIN S/SU
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12537704
MDR Text Key273551784
Report Number3003916417-2021-00305
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number990256
Device Lot Number1022225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2021
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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