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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH NEEDLE; PISTON SYRINGE
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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 990407
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 9 bd plastipak¿ syringe with needles experienced damaged unit packaging where sterility was compromised.The following information was provided by the initial reporter: packages with torn package paper.
 
Event Description
It was reported that 9 bd plastipak¿ syringe with needles experienced damaged unit packaging where sterility was compromised.The following information was provided by the initial reporter: packages with torn package paper.
 
Manufacturer Narrative
Investigation summary photos received by our quality team for investigation.Damage packaged cannot be confirmed from the images, physical samples are necessary to further analyze.Retention samples from lot 0315944 were evaluated, no defects or issues observed.A device history record review showed no non-conformances associated with this issue during the production of this batch.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process for damaged package.
 
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Brand Name
BD PLASTIPAK¿ SYRINGE WITH NEEDLE
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 Key15465304
MDR Text Key301945040
Report Number3003916417-2022-00203
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990407
Device Lot Number0315944
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
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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