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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON UNSPECIFIED BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Extravasation (1842); Fever (1858); Infiltration into Tissue (1931); Pain (1994); Phlebitis (2004); Swelling/ Edema (4577)
Event Date 01/11/2022
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default. Medical device expiration date: unknown. Device manufacture date: unknown. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that while using an unspecified bd venflon¿ pro safety shielded iv catheter an adverse event occurred, but there does not appear to have been a problem with the device or the way it was used. The following information was provided by the initial reporter: "yes, i have encountered events resulting in patient or clinician injury that required medical or surgical intervention. ".
 
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Brand NameUNSPECIFIED BD VENFLON¿ PRO SAFETY SHIELDED 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13397146
MDR Text Key286266223
Report Number2243072-2022-00111
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
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

Patient Treatment Data
Date Received: 01/31/2022 Patient Sequence Number: 1
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