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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE LUER-LOK¿

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE LUER-LOK¿ Back to Search Results
Catalog Number 990175
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. (b)(6). Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed. The photo and the sample sent by the customer were verified and it was possible to observe scale marking missing. The probable cause for the defect is related to failure at printing system at the marking machine entrance, allowing the defect product flow of the process. Investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question. Samples/ photos analysis: a photo and sample were received, and it is possible observe scale marking missing. Dhr review: it was verified the batch record and the manufacturing date for this batch was january 2nd to 4th, 2018. 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 with each 2 hours at 24 parts; qn review: no quality notification (qn) could lead to this issue for the batches involved in this complaint are observed. Maintenance review: no maintenance records that could related to defect was observed. Conclusion: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed. The photo and the sample sent by the customer were verified and it was possible observe scale marking missing. The probable cause for the defect is related to failure at printing system at the marking machine entrance, allowing the defect product flow of the process. Root cause description: it was performed dhr evaluation and maintenance occurrence was observed. Based on this occurrence the potential causes for the problem is: failure at printing system at the marking machine; the defect identified from this complaint will be monitored for trend evaluation. Rationale: based on the severity and occurrence a capa is not required.
 
Event Description
It was reported that some of the bd plastipak¿ syringe luer-lok¿ syringes were missing the scale marking. Noticed prior to use. There was no report of exposure, injury, or medical intervention noted.
 
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Brand NameBD PLASTIPAK¿ SYRINGE LUER-LOK¿
Type of DeviceSYRINGE
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 Key7665249
MDR Text Key113544358
Report Number3003916417-2018-00140
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 foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990175
Device Lot Number7361552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2017
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: 07/05/2018 Patient Sequence Number: 1
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