MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	10012213
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that the user was priming the line for a blood transfusion and noticed that tubing disconnects at the spin collar and leaked.The customer stated ¿as if the area was not glued.".
Event or Problem Description
It was reported that the user was priming the extension tubing attached to 60 ml syringe for a blood transfusion when the user noticed that the tubing leaked at the hub when the cap was in place.The customer stated that "the tubing failure seems like it was if the area was not glued a space noted between the distal end tubing and spin collar where the leak occurred".It was later reported and confirmed by the rn that it was a user issue as the cap was left in place during the prime.When priming the tubing without the cap there was no leak noticed.The customer confirmed that there was no patient involvement.The event occurred in the nicu.
Additional Manufacturer Narrative
No product will be returned per customer.The customer¿s report of a "leak" with the cap in place was confirmed by the customer-provided photo.The customer¿s report of a "leak" with the cap in place was confirmed.However, the perceived "leak" is an overflow of the liquid as it exits the male luer and (over)fills the cap.The root cause of this failure was not identified.Entity changed from memorial city hospital mhhs to children¿s memorial hermann hospital.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8825418
• Report Number: 9616066-2019-02040
• Device Sequence Number: 2399390
• Product Code: FPA
• UDI-Device Identifier: 10885403233685
• UDI-Public: 10885403233685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10012213
• Device Catalogue Number: 10012213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1