MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 30893-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pain (1994)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that leaking is observed in the tubing to male luer engagement towards the side where epidural catheter's hub is connected.The customer pointed out the site of leak in the photo provided.There was no patient injury, however the patient was in pain due to not receiving the medication as it leaked out of the tubing.

Manufacturer Narrative

The customer¿s report that leaking was observed at the male luer engagement was confirmed.The sets were visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.A residual clear, colorless liquid was present within the sets.Visual inspection of the set noted no damage or any anomalies.Examination under magnification revealed some solvent channels at the exterior tubing and interior male luer surfaces that seemed more evident along the area of the yellow stripe of the microbore tubing.Functional and pressure testing confirmed small droplets leaking at the engagement between the tubing and the inlet port of the male luer on each set.The root cause is improper solvent application due to inadequate maintenance of the solvent dispenser and an improper holding time.This creates an inadequate interaction at the affected engagement that can lead to leaks after sterilization.

Event Description

It was reported that leaking was observed at the male luer engagement, the side where epidural catheter's hub is connected.There was no patient injury, however; the patient was in pain due to not receiving the medication, as it leaked out of the tubing.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the tubing leaks from the distal end where the port is connected.This is a recurring problem across multiple lots.The problem cannot be detected until the line is in the patient and m use.Discussed with staff m central distribution for this facility system.They are seeing this problem at multiple facilities and in multiple lots.The manufacturer has been notified and product has been returned.Multiple reports are being sent to the manufacturer about this problem.".

Manufacturer Narrative

Additional medwach information provided.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9282719
• MDR Text Key: 167175260
• Report Number: 9616066-2019-03127
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (y/n): N
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19046126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARROW EPIDURAL CATHETER, TD: (B)(6) 2019.