MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Air Embolism (1697)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog or a 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.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that air bubbles occurred during use with a unspecified bd nexiva catheter.The following information was provided by the initial reporter, "the ct department has experienced two air emboli in two different patients post scan.These patients came to the department with nexiva pivs in-situ, placed in the er.It is unclear if the individual initiating the iv pushed air into the patient vessel.The air emboli in each patient was in the 2 ml range, a much greater amount than the volume of the nexiva extension set.".

Manufacturer Narrative

H.6.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.H3 other text : see section h.10.

Event Description

It was reported that air bubbles occurred during use with a unspecified bd nexiva catheter.The following information was provided by the initial reporter, "the ct department has experienced two air emboli in two different patients post scan.These patients came to the department with nexiva pivs in-situ, placed in the er.It is unclear if the individual initiating the iv pushed air into the patient vessel.The air emboli in each patient was in the 2 ml range, a much greater amount than the volume of the nexiva extension set.".

• Brand Name: UNSPECIFIED BD NEXIVA CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9526818
• MDR Text Key: 173686766
• Report Number: 2243072-2019-02906
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention