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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CENTRAL VENOUS CATHETER

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BECTON DICKINSON UNSPECIFIED BD¿ CENTRAL VENOUS CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Air Embolism (1697)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. (b)(6). Investigation summary: since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event. Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.
 
Event Description
The following was reported by the customer when using a unspecified bd¿ central venous line. "the connection was described as "loose" by the health care worker, but the patient was agitated when it happened. Occurrence of a severe gas embolism following an accidental disconnection of a perfusion line on a central venous line. Current state of the patient: severe air embolism (neurological). ".
 
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Brand NameUNSPECIFIED BD¿ CENTRAL VENOUS CATHETER
Type of DeviceCENTRAL VENOUS 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 Key8344397
MDR Text Key136303104
Report Number2243072-2019-00245
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
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 Received01/25/2019
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: 02/15/2019 Patient Sequence Number: 1
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