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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 10ML SYRINGE SLIP TIP

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 10ML SYRINGE SLIP TIP Back to Search Results
Catalog Number 990558
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter:(b)(6). Investigation summary: after the evaluation of the received photos and the photo characteristic, this failure happened due to an incorrect setup, where the operator did not empty the feeder to make the paper change in the sealing station of the machine. The retention samples were evaluated and no failure was observed. Batch history analysis was performed, quality notifications and maintenance records were checked where no records potentially related to failure were found. The operators of the production line will be notified about 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: batch history analysis was performed, quality notifications and maintenance records were checked where no records potentially related to failure were found. The retention samples were evaluated and no failure was observed. After the evaluation of the received photos and the photo characteristic, this failure happened due to an incorrect setup, where the operator did not empty the feeder to make the paper change in the sealing station of the machine. The operators of the production line will be notified about the occurrence. Notification will be registered in the note: (b)(4). Additionally the incident identified from this complaint will be monitored for trend assessment.
 
Event Description
It was reported that 8 bd plastipak¿ 10ml syringe slip tips experienced damaged or open unit packaging/seals where sterility was compromised. The following information was provided by the initial reporter: product double labeled, but the package hasn't been sealed, letting the syringes open.
 
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Brand NameBD PLASTIPAK 10ML SYRINGE SLIP TIP
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 Key11646112
MDR Text Key247260363
Report Number3003916417-2021-00075
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 04/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990558
Device Lot Number0329782
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 Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2020
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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