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

Catalog Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Event Description

It was reported while using an unspecified bd nexiva catheter the tubing ruptured.There was no report of patient impact.The following information was provided by the initial reporter: issue: they had an iv in and injected contrast and it blew open when contrast was injected.

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 18-oct-2022.H.6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used nexiva catheter assembly.Upon inspection of the received device, it was identified that the extension tubing has expanded and ruptured near the catheter adapter.The reported issue was confirmed.An inspection of the extension tubing, and its connections was performed to identify if any manufacturing related occlusions were present.No manufacturing created occlusions were found indicating that the defect most likely originated due to use.The extension tubing cross section was measured and found to be within specification.Per the ifu (instructions for use), the maximum power injector pressure limit is 300psi.If this pressure limit is exceeded ballooning leading to bursting is likely to occur.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using an unspecified bd nexiva catheter the tubing ruptured.There was no report of patient impact.The following information was provided by the initial reporter: issue: they had an iv in and injected contrast and it blew open when contrast was injected.

• Brand Name: UNSPECIFIED BD NEXIVA CATHETER
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15744284
• MDR Text Key: 305170688
• Report Number: 2243072-2022-01895
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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