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

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).".

• Brand Name: UNSPECIFIED BD¿ CENTRAL VENOUS CATHETER
• Type of Device: CENTRAL 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 Key: 8344397
• MDR Text Key: 136303104
• Report Number: 2243072-2019-00245
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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 Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention