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

Model Number	30262E
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: non bd microclave;non bd 10 ml monoject syringe;icu medical trifuse.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that the extension tubing connected to a nonbd tri-fuse tubing disconnected from the part that connects on the pt line (rotating luer).There was no harm.
Additional Manufacturer Narrative
The customer¿s report of a tubing disconnection was not confirmed.The separated spin collar and mated non-bd trifuse set were not returned and therefore could not be evaluated for damage or anomalies that might have contributed to the reported disconnection.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found the male luer spin collar had separated from the male luer on model 30262e.The root cause of the customer¿s report could not be identified.No anomalies were observed with extension set model.
Event or Problem Description
It was reported that the extension tubing connected to a non bd tri-fuse tubing disconnected from the part that connects on the pt line (rotating luer).It was confirmed during follow up that there was no patient harm as a result of this event.

• 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: 8782265
• Report Number: 9616066-2019-01958
• Device Sequence Number: 19301881
• Product Code: FPA
• UDI-Device Identifier: 07613203011471
• UDI-Public: 7613203011471
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Expiration Date: 03/08/2022
• Device Model Number: 30262E
• Device Catalogue Number: 30262E
• Device Lot Number: 19035721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ME2050, TD (B)(6) 2019