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

Lot Number 68689

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Event Description

It was reported to quest by (b)(6) medical center of an alleged leak with product code pdtv05fa.No patient complications were reported.

Manufacturer Narrative

Quest received the suspect device from (b)(6).After decontamination of the sample, testing of the device noted an occlusion in the filter.After clearing the occlusion, there was a leak that was noted in the line with the blue slide clamp.Investigation of the device noted that all three lines of tubing were fully inserted into the bond pocket, which indicates proper solvent application.The customer reported that the sets were changed out every 96 hours.Per the device ifu, it is recommended to change out the set every 72 hours.Additionally, it is noted that if the sets are utilized for lipid infusions, leaving solutions for this length of time can cause the lipid solution to warm and stop line patency, leading to occlusions.The root cause of this complaint was noted to be leaking due to occlusion of the set due to failure to swap the set out after 72 hours.Quest has concluded its investigation of this complaint condition.Quest will continue to monitor complaint trends.

• Brand Name: PRECISION DELIVERY IV SETS
• Type of Device: 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: 17846165
• MDR Text Key: 324622387
• Report Number: 1649914-2023-00028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00634624921023
• UDI-Public: 00634624921023
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 68689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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