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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON UNSPECIFIED BD CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 04/03/2020
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog or a 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. Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received.   the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. We would be very interested in examining product that does not meet your expectations and our quality standards. Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis. Examination of the product involved may provide clarification as to the cause for the reported failure. We appreciate you taking the time to bring this observation to our attention. 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. Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed. Root cause description: no root cause can be determined as no samples were received.
 
Event Description
It was reported that leakage occurred during use with a unspecified bd catheter. The following information was provided by the initial reporter, "the patient went to the hospital of for treating the cough and expectoration,the patient was diagnosed with lung abscess, doctor's advised to give the ns 250 ml + cefoxitin injection for intravenous infusion with the bid, on the second day the patient went to community hospital to continue the treatment, the nurse gave intravenous infusion, the family found problems during infusion with less than ten minutes, the fluid seepage continuously from the puncturing site, the nurse checked and found liquid oozed out from the joint of y-shape tube and needle hub. So the nurse informed the patient's family that they needed to pull out the needle and repunctured again. After giving explanation and apology to patient and his family, the family agreed to puncture again. ".
 
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Brand NameUNSPECIFIED BD CATHETER
Type of DeviceINTRAVASCULAR CATHETER
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
8015652341
MDR Report Key10014791
MDR Text Key190147718
Report Number2243072-2020-00706
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
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 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received04/21/2020
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: 04/30/2020 Patient Sequence Number: 1
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