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

Model Number	PDB05CV1
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was provided in medwatch form 2233020000-2022-8066, which stated that the devices in question was frequently breaking, requiring new set-up and replacement during infusions.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.
Event or Problem Description
It was reported to quest medical by children's hospital of boston of an alleged issue with precision delivery sets.The report stated that the set bonding was allegedly not holding and that there was an instance of blood stream infection.

• Brand Name: PRECISION DELIVERY IV SETS
• Common Device Name: IV 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: 15696038
• Report Number: 1649914-2022-00029
• Device Sequence Number: 6801127
• Product Code: FPA
• UDI-Device Identifier: 00634624921382
• UDI-Public: 00634624921382
• 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): 10/28/2022

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 Expiration Date: 06/06/2025
• Device Model Number: PDB05CV1
• Device Lot Number: 66292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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