MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383516

Device Problem Material Deformation (2976)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 was reported that nexiva 20 ga x 1 in single port tubing was bubbling.The following information was provided by the initial reporter: it was reported by the medical professional, the extension tubing gad a bubble during a ct scan.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-20.H6: investigation summary 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 the 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.As the pressure setting was not provided and cannot be verified, this is a possible scenario.Ballooning of tubing may also occur if there is an obstruction or kinks in the tubing during pressure injection.A microscopic inspection of the extension tubing was performed and no obstruction was found.This does not mean a temporarily occlusion did not occur during the injection; however, this too cannot be verified.Although the reported defect was confirmed, bd was unable to determine which scenario was more likely.A device history record review could not be performed as the lot number was not confirmed.

Event Description

It was reported that nexiva 20 ga x 1 in single port tubing was bubbling.The following information was provided by the initial reporter: it was reported by the medical professional, the extension tubing gad a bubble during a ct scan.

• Brand Name: NEXIVA 20 GA X 1 IN SINGLE PORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12701339
• MDR Text Key: 278613371
• Report Number: 1710034-2021-00915
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835164
• UDI-Public: 00382903835164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• 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