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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ANGIOCATH CATHETER

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BECTON DICKINSON UNSPECIFIED BD ANGIOCATH CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Death  
Manufacturer Narrative
Date of death: unknown. Date of event: unknown. The date received by manufacturer has been used for this field. 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. (b)(4). Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. 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. Root cause is undetermined. No sample, lot, or batch provided.
 
Event Description
It was reported that there was an infection on 41 occasions while using unspecified bd¿ angiocath catheter. The following information was provided by the initial reporter: material no: unknown, batch no: unknown. It was reported via post market survey that clinicians encountered occurrences of bloodstream infections (e. G. Blood stream bacteraemia, sepsis) (41), phlebitis (134), infiltration / extravasation (220), catheter occlusions (174), and primer failure (1). Additional information related to bloodstream infection: "wide-spectrum antibiotic therapy and long hospital" (528). Additional information related to bloodstream infection: "antibiotic therapy. " (568). Additional information related to death following bloodstream infection: "a death by sepsis took place that could be related or not with the use of the catheter, because the sepsis could be due to another type of catheter or by surgery practiced to the patient. As i always say in this type of surveys the answers are rather approximate, as it is impossible to keep a complete track of each patient from the last years i¿ve been working. " (568).
 
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Brand NameUNSPECIFIED BD ANGIOCATH CATHETER
Type of DeviceCATHETER
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11813208
MDR Text Key250236536
Report Number2243072-2021-01416
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
UNKNOWN
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
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
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: 05/12/2021 Patient Sequence Number: 1
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