MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20GA 1.25IN HF Y; PERIPHERAL IV CATHETERS

Catalog Number 383537

Device Problem Stretched (1601)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva 20ga 1.25in hf y tubing ballooned.The following information was provided by the initial reporter: we got a patient in from the er who had a nexiva, it went well to flush nacl and no problems getting backflow.But when using the pressure syringe, the pressure went up to over 300psi.When the nurse went in to check, the tube had dilated as you can see in the picture.The "clamp" was opened, but it seems that it is after the "kink" that it has widened.Nexiva the tube had dilated.During use.19 oct 2023 email response: has there been any patient impact (serious injury, medical intervention, change of treatment required)? : no.Has there been any healthcare worker¿s exposure to blood or bodily fluids? : no.Have any other actions been taken? : no.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs.The first photograph displayed an inserted 20g nexiva iv catheter that was secured to the patient's arm.At the time the photo was taken, the clamp was in the closed position.A non-bd injection cap was attached to each luer adapter.A dark colored material, which was likely blood residue, was observed in sections of the extension tubing.A section of extension tubing between the dual port adapter and the clamp was ballooned and expanded in diameter.The second photograph displayed a monitor with what appeared to be the injection pressures that were charted over time.A line on the chart was observed to mark 300 psi.The actual pressure appeared to slightly exceed 300 psi for some time.The max pressure setting appeared to be set to 350 psi.Although the actual pressure appeared to exceed300 psi, the pressure plot doesn't appear to approach 350 psi on the chart.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Without the physical sample, further testing could not be performed.Per the ifu(instructions for use), the maximum power injector pressure limit is 300psi.If this pressure limit is exceeded, ballooning is likely to occur.Additionally, a ballooned tubing may occur due to the tubing being kinked or occluded during pressure injection.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

Event Description

No additional information.

• Brand Name: BD NEXIVA 20GA 1.25IN HF Y
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18026695
• MDR Text Key: 326818569
• Report Number: 1710034-2023-01235
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835370
• UDI-Public: (01)30382903835370
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: Other
• Device Catalogue Number: 383537
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/28/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1