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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER

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BECTON DICKINSON UNSPECIFIED BD CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Extravasation (1842); Hematoma (1884); Unspecified Infection (1930)
Event Date 01/25/2021
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. Initial reporter phone#: (b)(6). Device manufacture date: unknown. (b)(4). 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. Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
 
Event Description
It was reported that there was an infection after using unspecified bd¿ catheter. The following information was provided by the initial reporter: material no: unknown batch no: unknown. It was reported via post market survey that there were occurrences of infiltration / extravasation (10), localised iv site infections (e. G. Cellulitis, abscess, phlebitis, thrombophlebitis) (2), and hematomas (10).
 
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Brand NameUNSPECIFIED BD 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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11359174
MDR Text Key241452360
Report Number2243072-2021-00506
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
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 Received01/25/2021
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: 02/22/2021 Patient Sequence Number: 1
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