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

Model Number PDB05CV1

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Unspecified Infection (1930)

Event Date 09/30/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 302679308
• Report Number: 1649914-2022-00029
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00634624921382
• UDI-Public: 00634624921382
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1