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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHENA IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON UNSPECIFIED BD CATHENA IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problems Bruise/Contusion (1754); Inflammation (1932)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the unspecified bd cathena¿ iv catheter leaked blood from the flashback chamber. The following information was provided by the initial reporter, translated from (b)(6) to english: "since we have been using the new cathlons for about a month, we and our colleagues have noticed that they bleed much more at the puncture site, that there is more haematoma above the puncture site, the veins are more inflamed and also more inflammations. Then while these are the so-called anti-reflux cathlons we sometimes find that this system is failing because there is a reflux of blood. ".
 
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Brand NameUNSPECIFIED BD CATHENA IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10946044
MDR Text Key219557256
Report Number2243072-2020-01996
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
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,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received12/22/2020
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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