MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Embolism (1829)

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 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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that one unspecified bd¿ catheter has been found with air bubbles in the line during use.The following has been provided by the initial reporter: material no.: unknown batch no.: unknown.It was reported air embolism in two patients with nexiva catheters.Per complaint form: 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.

Event Description

It has been reported that one unspecified bd¿ catheter has been found with air bubbles in the line during use.The following has been provided by the initial reporter: material no.: unknown.Batch no.: unknown.It was reported air embolism in two patients with nexiva catheters.Per complaint form: 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 item number, 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.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9521782
• MDR Text Key: 173047900
• Report Number: 2243072-2019-02898
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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

• Date FDA Received: 12/26/2019
• 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
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention