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

Model Number	PDTV05F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to quest medical of an alleged issue with product code pdtv05f.The report stated that the line was allegedly compromised and fluid leaking was noted.An allegedly low blood glucose level was reported.
Additional Manufacturer Narrative
Quest medical is still pending receipt of the device and additional information.A supplement will be filed upon the completion of this complaint investigation.
Additional Manufacturer Narrative
Quest recieved the subject device and performed the investigation.The results of the investigation confirmed the complaint condition of leaking.The root cause of the leaking was determined to be due to the tubing not being fully inserted into the bond pocket, which resulted in fluid leaking out of the bond pocket.Quest has concluded its investigation of this device.Quest will continue to monitor complaint trends for this condition.

• Brand Name: PRECISION DELIVERY IV SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 17135809
• Report Number: 1649914-2023-00019
• Device Sequence Number: 11744674
• Product Code: FPA
• UDI-Device Identifier: 00634624621152
• UDI-Public: 00634624621152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: 09/06/2025
• Device Model Number: PDTV05F
• Device Lot Number: 67184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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