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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD¿ VENFLON CATHETER INTRAVASCULAR CATHETER

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UNSPECIFIED BD¿ VENFLON CATHETER INTRAVASCULAR 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); Phlebitis (2004)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
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. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. No root cause can be determined as no samples were received. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. A capa is not required at this time.
 
Event Description
It was reported unspecified bd¿ venflon catheters had reports of 10 issues with infection and 20 issues with extravasation. The following information was provided by the initial reporter: "it was reported via post market survey that clinicians encountered cannula related bloodstream infection (e. G. Blood stream bacteraemia, sepsis) (10). Extravasation (not related to high pressure injection of contrast media) (10), extravasation with high pressure injection of contrast media (10)".
 
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Brand NameUNSPECIFIED BD¿ VENFLON CATHETER
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12669134
MDR Text Key278425735
Report Number2243072-2021-02564
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 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
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: 10/20/2021 Patient Sequence Number: 1
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