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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 Product Quality Problem (1506); Use of Device Problem (1670)
Patient Problems Extravasation (1842); Venipuncture (2129); Wheal(s) (2241); Blood Loss (2597)
Event Date 03/05/2020
Event Type  Injury  
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 catheter infiltrated the patient's vein during use. This complaint was created to capture the 3rd of 3 related incidents. The following information was provided by the initial reporter: "it was reported that catheters are hard to thread causing multiple sticks to the patient, blowing and infiltrating veins, wings are causing damages to the patients skin, and needles are flimsy. ".
 
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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 Key10231325
MDR Text Key201744067
Report Number2243072-2020-00997
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? 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 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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