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

Model Number	PD06F
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
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 (b)(6).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 retained in quest inventory.Testing of all of these devices were unable to replicate the reported complaint condition.Quest will continue to monitor trends for this complaint condition.
Event or Problem Description
It was reported to quest medical by (b)(6) of an alleged issue with precision delivery set, stating that the tubing was allegedly pulling apart at the bonding.

• Brand Name: PRECISION DELIVERY IV SETS
• Common Device Name: IV ADMINISTRTATION 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: 15643065
• Report Number: 1649914-2022-00023
• Device Sequence Number: 6460852
• Product Code: FPA
• UDI-Device Identifier: 00634624911062
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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 Model Number: PD06F
• 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: 09/20/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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