MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Eye Injury (1845)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the tubing separated at pump segment while attempting to insert the safety clamp back into the pump after the clinician flicked the set to remove the air bubbles.The unspecified fluid splashed onto the clinician's right eye.The tubing was immediately clamped to avoid further leak and asked another staff to replace the tubing.The clinician's eye was cleansed with tap water and received saline irrigation for about thirty seconds as the tap water did not help with the burning discomfort.The clinician was sent to the emergency department (ed), ocular movements and visual acuity were checked.No further inflammation noted on the right eye and the clinician was discharged from the ed and returned to the patient care unit.The event occurred in adult bone marrow transplant unit (bmt).Although requested, additional information was not provided.

• Brand Name: PRIMARY TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9836803
• MDR Text Key: 184481949
• Report Number: 9616066-2020-00848
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention