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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD¿ VENFLON CATHETER

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UNSPECIFIED BD¿ VENFLON CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Event Date 08/19/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. 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. Medical device expiration date: unknown. Device manufacture date: unknown. 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. 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. Capa is not required at this time.
 
Event Description
It was reported that unspecified bd¿ venflon catheter was used and the clinician experienced an infection, phlebitis on 28 occasions, and infiltration on 10 occasions. The following information was provided by the initial reporter: it was reported via venflon pmcf survey that the clinician experienced cannula related bloodstream infection (e. G. Blood stream bacteraemia, sepsis),phlebitis, infiltration, extravasation (not related to high pressure injection of contrast media), cannula occlusion, extravasation with high pressure injection of contrast media within the past 2 months.
 
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Brand NameUNSPECIFIED BD¿ VENFLON CATHETER
Type of DeviceCATHETER
MDR Report Key12482840
MDR Text Key271748470
Report Number2243072-2021-02335
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
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: 09/16/2021 Patient Sequence Number: 1
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