MAUDE Adverse Event Report: CAREFUSION EXTENSION TUBING SETS; INTRAVASCULAR ADMINISTRATION SET

Model Number EXT TUBING

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ device ct alarm went off because of an occlusion.The nurse noticed there was blood leakage because of the tubing being damaged.The following information was provided by the initial reporter: material no: unknown batch no (lot no): unknown it was reported the device's ct alarm went off due to occlusion.The email i received from the nurse stated: ¿i was in ct with a patient who needed contrast and had to be monitored.The ct alarmed after a few minutes with an occlusion.When we went to investigate and the j-loop had split with blood and contrast leaking everywhere making it very difficult to fix.I don't know if it was due to the contrast or if it was just a fluke but this is the first time i've seen this happen since using them.¿ after speaking with the team leader he said it was the actual tubing was split.

Manufacturer Narrative

The following fields have been updated with corrections: b.5.Describe event or problem: it was reported that extension tubing sets tubing split resulting in leakage.The following information was provided by the initial reporter: material no: unknown batch no (lot no): unknown.It was reported the tubing split resulting in leakage of blood and contrast.The email i received from the nurse stated: ¿i was in ct with a patient who needed contrast and had to be monitored.The ct alarmed after a few minutes with an occlusion.When we went to investigate and the j-loop had split with blood and contrast leaking everywhere making it very difficult to fix.I don't know if it was due to the contrast or if it was just a fluke but this is the first time i've seen this happen since using them.¿ after speaking with the team leader he said it was the actual tubing was split.D.1.Brand name: extension tubing sets.D.4.Model #: ext tubing.D.4.Catalog #: ext tubing.H.6.Device codes: 1354.H.6.Patient codes: 2597.H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint of the tubing splitting 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 or lot number was not provided by the customer.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that extension tubing sets tubing split resulting in leakage.The following information was provided by the initial reporter: material no: unknown batch no (lot no): unknown.It was reported the tubing split resulting in leakage of blood and contrast.The email i received from the nurse stated: ¿i was in ct with a patient who needed contrast and had to be monitored.The ct alarmed after a few minutes with an occlusion.When we went to investigate and the j-loop had split with blood and contrast leaking everywhere making it very difficult to fix.I don't know if it was due to the contrast or if it was just a fluke but this is the first time i've seen this happen since using them.¿ after speaking with the team leader he said it was the actual tubing was split.

• Brand Name: EXTENSION TUBING SETS
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10239167
• MDR Text Key: 198314477
• Report Number: 9616066-2020-02122
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXT TUBING
• Device Catalogue Number: EXT TUBING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other