MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.E1.Address information was not provided, therefore, (b)(6) was used as a place holder.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that a bd nexiva disconnected during ct contrast injection.The following information was provided by the initial reporter: encountered a defective bd nexiva ultrasound guided piv product that disconnected during ct contrast injection.The iv was in the patient¿s left upper arm and had positive blood return and flushed easily prior to scan.A manual test with a saline flush was done prior to injection when the clear tubing disconnected from the pink (butterfly) portion of the iv.The patient was with without complaints and no harm was done.

Event Description

Additional information received: 1) was there exposure of wounds or mucosal surfaces to blood/body fluids? no 2) was ppe worn during the procedure? if so, please explain.Gloves per standard precautions requirement.3) were there any injuries reported in response to this complaint? no reported injuries 4) was there permanent impairment to body functions or damage to body structures? no.

Manufacturer Narrative

Additional information: date of event provided and additional information about event provided and updated in b5 investigation results: the complaint that the extension tubing separated from the catheter adapter was confirmed; however, the root cause could not be determined from the three photographs that were provided for investigation.The photos showed a 20g nexiva unit with evidence of use.It appeared that the extension tubing completely separated from the catheter adapter.No defects associated with the manufacturing process could be discerned from the photographs.As the device had been opened and exhibited evidence of use, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD NEXIVA
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18753611
• MDR Text Key: 336895648
• Report Number: 1710034-2024-00121
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1