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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA 5 ML BD PLASTIPAK LUER-SLIP SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA 5 ML BD PLASTIPAK LUER-SLIP SYRINGE Back to Search Results
Catalog Number 990317
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reported addr 1: (b)(6). Investigation summary: evaluating the images provided it was possible to observe empty packaging and loose parts. Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect. According to the investigation carried out, a possible cause of the defect could have been operational failure when packaging the product. The operator put the discarded packaging together with the material and did not see that a loose part without packaging was in the box. We inform that the current controls to detect the incident are performed through visual inspection in the packaging process. The operators of the production line will be notified of the occurrence. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: checked the quality notifications and maintenance records, and found no potential records related to the failure. However, it was possible to confirm the deviation through the analysis of the photo sent by the customer. The operators of the production line will be notified of the occurrence, it will be registered in the note: (b)(4).
 
Event Description
It was reported that 10 5 ml bd plastipak¿ luer-slip syringes experienced damaged or open unit packaging/seals where sterility was compromised. The following information was provided by the initial reporter: product's package is empty, and one syringe loose without package inside the sealed box.
 
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Brand Name5 ML BD PLASTIPAK LUER-SLIP SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11691103
MDR Text Key272030022
Report Number3003916417-2021-00081
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
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 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990317
Device Lot Number0120083
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 Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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