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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ VENFLON CATHETER

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BECTON DICKINSON 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); Phlebitis (2004)
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: no photograph and no sample received and available for investigation. The retention samples could not be used for investigation as the lot number is unknown. No investigation is possible as there is no sample or lot number reported by the customer. The exact root cause of blood stream infections and phlebitis cannot be confirmed due to unavailability of the sample or the lot number. Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. A complaint history check was not performed as the lot number is "unknown" for this complaint. A device history record review could not be performed because a model or lot number was not provided by the customer. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Capa is not required at this time.
 
Event Description
It was reported that unspecified bd¿ venflon catheter was used and the clinician experienced infections on 7 occasions and phlebitis on 4 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 within the past 2 months.
 
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Brand NameUNSPECIFIED BD¿ VENFLON CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12482846
MDR Text Key271747002
Report Number2243072-2021-02337
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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