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

Catalog Number	PDTV05FA
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	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest has not yet received the device from (b)(6) for investigation.A review of the production records indicated that the complaint condition's root cause could have possibly been due to insufficient solvent bonding in the bond pocket, but the complaint could not be confirmed.Quest will file a supplemental report, should any additional information become available for this complaint condition.Quest has concluded its investigation.Quest will continue to monitor complaint trends for this complaint condition.
Event or Problem Description
(b)(4) was recieved from the fda on 08/28/2023.The report stated that an amber infusion set was found snapped and disconnected from the filter, and that blood was backed up in the blue picc connection.The infusion pump was also alarming for occlusion.No patient complications were noted.

• Brand Name: PRECISION DELIVERY IV SETS
• Common Device Name: 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: 17785905
• Report Number: 1649914-2023-00027
• Device Sequence Number: 7750547
• Product Code: FPA
• UDI-Device Identifier: 00634624921023
• UDI-Public: 00634624921023
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

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: 07/17/2025
• Device Catalogue Number: PDTV05FA
• Device Lot Number: 66776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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