MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD DEHP FREE 4 IN EXT SET W/ANTSPHN VLV DET; INTRAVASCULAR ADMINISTRATION SET

Model Number	C25012
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd dehp free 4 in ext set w/antsphn vlv det separated during use.The following information was provided by the initial reporter: the anti syphon line came apart at the middle connection and the chemotherapy line hit the ground.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of the anti-syphon line coming apart at the middle connection could not be verified due to the product not being returned for failure investigation.Device history record review for model c25012 lot number 21059533 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.The reported set is a simple extension set, and has no hand tightened connections that could have been an issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD DEHP FREE 4 IN EXT SET W/ANTSPHN VLV DET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: ryan reynolds ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15163372
• Report Number: 9616066-2022-01044
• Device Sequence Number: 12385661
• Product Code: FPA
• UDI-Device Identifier: 50885403235618
• UDI-Public: 50885403235618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 05/24/2024
• Device Model Number: C25012
• Device Catalogue Number: C25012
• Device Lot Number: 21059533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown