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U.S. Department of Health and Human Services

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

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BECTON DICKINSON UNSPECIFIED BD IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Retraction Problem (1536)
Patient Problems Venipuncture (2129); Wheal(s) (2241); Blood Loss (2597)
Event Date 03/03/2020
Event Type  malfunction  
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. (b)(4). 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. 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. Rationale: capa is not required at this time.
 
Event Description
It was reported that the unspecified bd¿ iv catheters were difficult to advance, blew veins, and threaded incorrectly during use. This caused blood leakage around the connection. Additionally, it was reported that the retraction button was difficult to activate, and the catheter was "more likely" to turn upside down while placing the dressing or flushing the line. This complaint was created to capture the 1st of 3 related incidents. The following information was provided by the initial reporter: "it was reported that catheters are difficult to advance, blowing veins and sometimes threading incorrectly causing blood to leak around the connection. The wingtips cause pressure points at the tips and the retraction button is difficult to activate. Also the catheter is also more likely to turn upside down while placing dressing or flushing the line. ".
 
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Brand NameUNSPECIFIED BD IV 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 Key10231305
MDR Text Key198611638
Report Number2243072-2020-00996
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received06/22/2020
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: 07/06/2020 Patient Sequence Number: 1
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