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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381137
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 06/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: there was no sample or photo available to bd for evaluation. Therefore, bd was unable to perform a thorough investigation to verify the reported issue. Since, an investigation could not be performed bd was unable to determine a possible root cause. The manufacturing facility has been notified of this incident and the findings. A review of the device history record was performed and no quality issues were found during production. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that black foreign matter was found on the bd angiocath¿ iv catheter cannula. The following information was provided by the initial reporter, translated from (b)(6) to english: "at 10 am on (b)(6) 2020, the patient with 8 beds need invasive blood pressure monitoring. During the quality inspection before the arterial puncture, a black foreign matter was found in the cannula of the disposable venous indwelling needle. Discard the indwelling needle immediately. No adverse effects on patients. ".
 
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Brand NameBD ANGIOCATH IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11182450
MDR Text Key227475977
Report Number9610048-2021-00013
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151698
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 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381137
Device Catalogue Number381137
Device Lot Number8351727
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 Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2018
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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