MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Leak/Splash (1354); Free or Unrestricted Flow (2945); Material Deformation (2976)

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

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint that they had significant priming, air in line, separation, flow accuracy, backflow issues where the secondary infuses into the primary and leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no product will be returned per customer.No investigation was performed.

Event Description

It was reported that unspecified bd intravascular administration set experienced 3 cases of flow issues, 1 case of check valve malfunction, 1 case of component separation, and 1 case of leakage.The following information was provided by the initial reporter: the hospital reported multiple disposable and device issues.There is no further information available for the complaints.Difficulty priming albumin/ ivig & air-in-line (ail) issues with albumin/ivig: many issues priming albumin and ivig with iv set.Very slow to prime or flow becomes blocked all together.Multiple units reporting this issue: oncology, critical care, medical day care units.Units reporting 2 out of 3 iv sets are difficult to prime.For the most part nurses can get the tubing to prime ¿with patience¿, but in other settings where they don't have 2-3 minutes to get it to prime, they are changing iv sets and re-spiking the bottle 2-3 times, pulling the fluid down with a syringe or sticking a blunt needle in the vent or the rubber stopper to help flow (which increases risk of contamination and leaking).This is particularly significant in the icu setting where they have needed albumin in critical situations.In these situations they have ended up needing to give the patients additional vasopressors or fluid boluses (neither of which is ideal) because they couldn't hook the albumin up fast enough.Significant air-in-line with ivig and albumin infusions.Air-in-line alarms have delayed infusions due to time spent troubleshooting microscopic bubbles in tubing.Some pumps alarm extremely frequently, every 15 minutes.Ail is particularly troublesome with the 2nd and 3rd bottles of albumin and ivig which are larger volumes and faster rates.Nurses say the ail sensor is ¿very sensitive¿.False ail alarms with iron infusions: nurse reports frequent false ail alarms with iron infusions.Ail issues with cyclosporine: many ail issues also with cyclosporine.The hospital changed cyclorsporine from a continuous infusion to a 4hour bolus dose at a faster rate.This has helped a little bit, but they are still getting frequent issues.Patients are getting frustrated because they are not sleeping.Pumps shutting down without warning: if you shake the pumps even a little bit, the channel comes off.¿they come off so easily¿.This is an issue when there are inotropes running.A few weeks ago they had an unstable patient where the physician had to accompany the patient to scans, and the pump turned off without any warning.They were running large amounts of medication that were life supporting.For example: levo and propofol.Their biomed will look at the event logs and see that the pump is over estimating the battery life left on the pump.For example: so the pump has 3 hours left and that is more than enough time to get to scans, especially when they plug it in while they are there.But then after 15 minutes the pump will shut off.Potential back check valve failures: arsenic infusing faster than expected.Infused in 20 minutes rather than 2 hours.Multiple instances of chemotherapy and antibiotics infusing faster than expected.Eg.Ar-c (chemo) and pip-tazo (antibiotic).There was one instance where there were 3-4 anti-biotics infusing into the primary bag, before they noticed that the secondary anti-biotic were infusing into the primary iv bag.Therefore the patient was not receiving the intended dose at the intended rate.Clinicians note that these type of events tend to happen 72 hours into using a primary iv set.They notice a ¿back check valve failure¿ if the bag is empty sooner than expected, if they spike the bag and suddenly there is fluid pouring out of the drip chamber, or if they see the primary bag expanding.The biggest ¿tell¿ for them is when they see the primary drip chamber fill up.In all events, there has been patient involvement, but harm is unknown.There is no further information available.

• Brand Name: UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12346298
• MDR Text Key: 267425368
• Report Number: 2243072-2021-02126
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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?: No
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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