MAUDE Adverse Event Report: CAREFUSION SEC SET 15DP W/HANGER DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	72215N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics was not provided.
Event or Problem Description
It was reported that while priming iv potassium, tubing separated below the drip chamber.There was no patient involvement.Although requested, additional information was not provided.
Event or Problem Description
It was reported that while priming iv potassium, the tubing separated below the drip chamber.There was no patient involvement.Although requested, additional information was not provided.
Additional Manufacturer Narrative
Additional information added to; b.7 & d.10.The customer¿s report that the tubing separated below the drip chamber was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection observed a separation at the engagement between the tubing and drip chamber¿s outlet port.Closer inspection observed that the tubing had insufficient solvent applied at engagement during manufacturing process.No other anomalies were observed with the set.The tubing¿s internal diameter and the drip chamber port¿s outer tubing diameter were measured and found to be within specification(s).Functional testing could not be performed on the set due to a leak that would occur from the separation.The root cause was identified as a manufacturing issue for insufficient solvent being applied at the engagement of the tubing due to equipment and/or operator error.

• Brand Name: SEC SET 15DP W/HANGER DEHP FREE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9574738
• Report Number: 9616066-2020-00107
• Device Sequence Number: 3230143
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: 10885403235467
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/19/2019

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: 09/19/2022
• Device Model Number: 72215N
• Device Catalogue Number: 72215N
• Device Lot Number: 19093182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1