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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK LUER-LOK SYRINGE; PISTON SYRINGE
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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK LUER-LOK SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 990174
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
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 that 200 bd plastipak¿ luer-lok¿ syringes leaked lidocaine during use.The following information was provided by the initial reporter, translated from portuguese to english: "reports that all syringes from the batch are with an issue in vacuum.The liquid is leaking in all of them." "there were no incidents, the only issue is with the vacuum of the stopper, that doesn't hold the liquid inside the syringe.Local anesthesia procedure, with lidocaine med.".
 
Event Description
It was reported that 200 bd plastipak¿ luer-lok¿ syringes leaked lidocaine during use.The following information was provided by the initial reporter, translated from portuguese to english: "reports that all syringes from the batch are with an issue in vacuum.The liquid is leaking in all of them." "there were no incidents, the only issue is with the vacuum of the stopper, that doesn't hold the liquid inside the syringe.Local anesthesia procedure, with lidocaine med.".
 
Manufacturer Narrative
H6: investigation summary no product samples or photos of the incident were made available, and it was not possible to confirm the complaint and carry out tests and investigation of the root cause.Additionally, batch retention samples were evaluated (we performed the leak test on 5 samples) and no defects were found in the product.The analysis of the batch history (dhr), maintenance records and quality notifications were verified, and no deviation was found for this batch.Production processes are validated according to defined acceptance criteria.The incident identified from this complaint will be monitored for trend assessment.
 
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Brand Name
BD PLASTIPAK LUER-LOK SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key12411809
MDR Text Key273466028
Report Number3003916417-2021-00242
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990174
Device Lot Number0350045
Was Device Available for Evaluation? No
Date Manufacturer Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age37 YR
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