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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ 2 - 20G INTRAVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ 2 - 20G INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391492
Device Problem Packaging Problem (3007)
Patient Problems Hypersensitivity/Allergic reaction (1907); Sepsis (2067)
Event Date 06/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). "multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 18e1741h, medical device expiration date: 2023-04-30, device manufacture date: 2018-11-01. Medical device lot #: 1880441m, medical device expiration date: unknown, device manufacture date: unknown. Medical device lot #: 1882341f, medical device expiration date: unknown, device manufacture date: unknown. " device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the package integrity is compromised, also reported that there have been 6-8 patients that had allergic reaction/sepsis with a bd venflon¿ 2 - 20g. This occurred during use, however, the date/time and or patient information is unknown. The following information was provided by the initial reporter: there has been 6-8 cases where patients reported skin allergic reaction/sepsis. Also the packaging seal integrity is compromised. Customer says that packaging paper¿s not stuck properly with the other end of unit level packaging.
 
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Brand NameBD VENFLON¿ 2 - 20G
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
8015652341
MDR Report Key8761066
MDR Text Key150121013
Report Number2243072-2019-01330
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391492
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? Yes
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: 07/03/2019 Patient Sequence Number: 1
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