MAUDE Adverse Event Report: CAREFUSION SMALLBORE Y-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 20019E

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

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.Although requested, no specific patient information was provided.

Event Description

It was reported that a set was missing an end during use.There was no patient harm.

Manufacturer Narrative

The customer¿s report that set was missing an end was confirmed.Visual inspection noted one of the two inlet ports of the bifurcated adapter did not have its expected mating tubing attached.The expected mating tubing, bonded smartsite valve, and slide clamp components were not received for evaluation.No other issues or damages were observed.Examination under magnification of the separated tubing end observed insufficient solvent and slight expansion.When aligning the tubing end alongside the outlet spigot of the drip chamber, based on the tubing slight expansion with the spigot end, it was observed that the tubing was not fully inserted.Functional testing was deemed unnecessary due to the separation.Further handling/tug of the rest of the set's tubing engagements observed no separation or any issues.The root cause was not identified.

Event Description

It was reported that a set was missing an end, during use.It was further confirmed during follow up, that there was no patient harm as a result of this event.

• Brand Name: SMALLBORE Y-CONNECTOR EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9227451
• MDR Text Key: 165262839
• Report Number: 9616066-2019-02990
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012010
• UDI-Public: 7613203012010
• Combination Product (y/n): N
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: 19065923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR