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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BECTON DICKINSON BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383012
Device Problems Leak/Splash (1354); Material Separation (1562)
Patient Problem Extravasation (1842)
Event Date 03/23/2022
Event Type  malfunction  
Event Description
It was reported that the bd intima ii¿ iv catheter prn adapter cap disconnected, leading to extravasation. The following information was provided by the initial reporter, translated from (b)(6) to english: the end of the heparin cap of the indwelling needle was detached when the iodine contrast agent was injected by the high-pressure pump, resulting in extravasation of blood and contrast agent.
 
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. Medical 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. Examination of the product involved may provide clarification as to the cause for the reported failure.
 
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Brand NameBD INTIMA II¿ IV CATHETER PRN ADAPTER
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14527274
MDR Text Key293167564
Report Number2243072-2022-00738
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383012
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
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

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