MAUDE Adverse Event Report: QUEST MEDICAL, INC. PRECISION DELIVERY IV EXTENSION SET, AMBER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	PDV60FA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during fluid delivery procedure, the device allegedly malfunctioned at the filter and subsequently the patient had to receive medical intervention due to further deterioration of health.The fluid delivery procedure was successfully completed.
Additional Manufacturer Narrative
Further investigation of the suspect device was conducted.The investigation on the returned sample confirmed the alleged malfunction, however, the device history record review showed that the bonding was adequate.Quest will continue to monitor complaint trends.

• Brand Name: PRECISION DELIVERY IV EXTENSION SET, AMBER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002 4211
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002 4211
• Manufacturer Contact: stephanie ajayi ; 1 allentown parkway; allen, TX 75002-4211 ; 9723326290
• MDR Report Key: 19779024
• Report Number: 1649914-2024-00004
• Device Sequence Number: 8031024
• Product Code: FPA
• UDI-Device Identifier: 00634624922044
• UDI-Public: 00634624922044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDV60FA
• Device Lot Number: 70931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown