MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number 2477-0007

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of an unspecified tubing issue was confirmed.Visual inspection of the set showed no signs of damage or abnormalities.Examination under magnification revealed a thin slit/tear in the tubing, in between the upper and lower fitments.Functional testing confirmed leaking from the silicone pump segment.The root cause was not determined.

Event Description

The customer submitted an administration set sample stating there was an unspecified issue with the tubing which the value analysis team was unable to discern.There was initially no report of patient involvement., however the received set had pockets of viscous, cloudy fluid through the tubing which indicated the potential of having been used on a patient.

• Brand Name: NON-VENTED BLOOD SET
• Type of Device: BLOOD SET
• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8206343
• MDR Text Key: 131718772
• Report Number: 9616066-2018-02609
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: 7613203019460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: 2477-0007
• Device Catalogue Number: 2477-0007
• Device Lot Number: 18057875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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