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

Model Number	PD06F
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in medwatch 2233020000-2022-8010 of an alleged incident involving quest precision delivery sets.In the report, it stated that these sets were allegedly leaking and breaking during ongoing iv infusions, resulting in new lines needing to be set up and replaced during various infusions.
Additional Manufacturer Narrative
Quest launched an investigation into this complaint.During the investigation, production records were reviewed for all lots of devices that were provided to children's hospital of boston (chob).Review of these records revealed no apparent production deficiencies related to weak bond strength or breakage.In addition to production record review, quest also performed failure analysis on complaint sample product codes that were received from chob, as well as those retained by quest.Results from testing were unable to replicate the complaint condition of weak weld/breakage.Quest will continue to investigate and monitor trends for this complaint condition.

• Brand Name: PRECISION DELIVERY IV SET
• Common Device Name: IV ADMINISTRATION SET
• 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: 16000430
• Report Number: 1649914-2022-00041
• Device Sequence Number: 5784176
• Product Code: FPA
• UDI-Device Identifier: 20634624911066
• UDI-Public: 00634624911062
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2022

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: 02/13/2025
• Device Model Number: PD06F
• Device Lot Number: 65163
• 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: 11/16/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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