MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD 20G NEXIVA IV CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd 20g nexiva iv catheter experienced tubing expansion/ballooning.The following information was provided by the initial reporter: material no: unknown batch no: unknown.I just want to notify you of a defective bd 20g iv nexiva that ballooned out during a ct scan at 299psi on the autoinjector.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/12/2021.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used unit.Upon inspection of the unit, it was observed that the extension tubing was ballooned confirming your reported defect.The ifu states a maximum power injector pressure limit setting of 300 psi.Exceeding specification can result in the ballooning of the extension tubing.Based on the event description, the power injection was within the acceptable range.Ballooning of tubing may also occur if there is an obstruction or kinks in the tubing during pressure injection.No kinks were observed in the tubing.Since media was present and dry, the device could not be tested for internal obstruction as clearing up dry media could remove any possible obstruction.Based on these observations, a cause for tubing ballooning was not determined.A device history record review could not be performed as the lot number is unknown.

Event Description

It was reported that the unspecified bd 20g nexiva iv catheter experienced tubing expansion/ballooning.The following information was provided by the initial reporter: material no: unknown.Batch no: unkownw.I just want to notify you of a defective bd 20g iv nexiva that ballooned out during a ct scan at 299psi on the autoinjector.

• Brand Name: UNSPECIFIED BD 20G NEXIVA IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11786826
• MDR Text Key: 268232717
• Report Number: 2243072-2021-01358
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1