MAUDE Adverse Event Report: CAREFUSION NON-VENTED SECONDARY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	72215N
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the set disconnected from the drip chamber and leaked was confirmed.Visual inspection of the set noted separation at the engagement between the tubing and drip chamber¿s outlet port.Closer inspection of the engagement under magnification observed insufficient solvent at the end of the tubing.No other anomalies were observed.Functional testing was not necessary as it is obvious that a leak would occur from this separation.The internal tubing diameter was measured and found to be within specification.The root cause of the customer¿s report was identified as a manufacturing issue due to no solvent being applied at the junction of the pvc tubing.
Event or Problem Description
It was reported that during a secondary rocephin infusion the set disconnected from the drip chamber and leaked.The rn stated that the set was in use for less than 24hrs.The customer confirmed that there was no delay in patient treatment.

• Brand Name: NON-VENTED SECONDARY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8890804
• Report Number: 9616066-2019-02311
• Device Sequence Number: 2514375
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: 10885403235467
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: 04/16/2022
• Device Model Number: 72215N
• Device Catalogue Number: 72215N
• Device Lot Number: 19046229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 48