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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 20GA X 1,16IN 1,1 X 30MM INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 20GA X 1,16IN 1,1 X 30MM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38833314
Device Problem Packaging Problem (3007)
Patient Problems Hyperemia (1904); Phlebitis (2004)
Event Date 11/17/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (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. 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. Investigation conclusion: not confirmed: bd was unable to confirm the complaint for the defects claimed. Root cause description: in addition to the lack of evidence that could cause this complaint during the analysis of the batch history, corrective maintenance and non-conformities, we did not receive photos and samples to carry out the analysis of the reported defect. Since an investigation could not be performed bd was unable to determine a possible root cause. Rationale: complaints received for this device and the reported defect will continue to be tracked and trended. The information will be captured in the trend reports and monitored monthly. Collected data are regularly reviewed to identify emerging trends. Based on this, a capa is not needed at this time.
 
Event Description
It was reported that the angiocath 20ga x 1,16in 1,1 x 30mm sterility was compromised and the patient developed phlebitis and hyperemia as a result. The following information was provided by the initial reporter, translated from portuguese to english: "phlebitis caused by abocath, hyperemia. ".
 
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Brand NameANGIOCATH 20GA X 1,16IN 1,1 X 30MM
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 Key11008570
MDR Text Key221455075
Report Number9610048-2020-00175
Device Sequence Number1
Product Code FOZ
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38833314
Device Lot Number8059650
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 Received11/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2018
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: 12/15/2020 Patient Sequence Number: 1
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