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U.S. Department of Health and Human Services

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

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BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 302631
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: confirmed: bd was able to confirm/ reproduce the incident in question. Samples/ photos analysis: evaluation of the returned sample showed plunger activation. Dhr review: the batch record and the manufacturing date for this batch was march 25th to 28th, 2017. The process inspections were performed and no records of this defect were found. The current controls at manufacturing process to detect the defect are performed by visual inspection each hour at 36 samples at assembly machine and activated plunger rejection system challenge each shift. Qn review: no quality notification (qn) that could related to defect were observed. Maintenance review: no maintenance records that could be related to the defect were observed. Conclusion: a dhr was performed, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed. Evaluating the complaint description and sample provided by the customer it was possible observe plunger activation. The potential cause for the reported problem is a jam at assembly process. The defect identified from this complaint will be monitored for trend evaluation.
 
Manufacturer Narrative
(b)(6). 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 during use of the bd solomed¿ syringe with needle when pulling the plunger in order to aspirate the medicine, the plunger releases, leaving the stopper inside the syringe. There was no report of injury or medical intervention.
 
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Brand NameBD SOLOMED¿ SYRINGE WITH NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7245372
MDR Text Key256293329
Report Number3003916417-2018-00006
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302631
Device Lot Number7054824
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/06/2018 Patient Sequence Number: 1
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