MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 T-EXTENSION SET; IV EXTENSION SETS

Model Number	95701
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received by quest medical from boston's children's hospital to report an issue with product code 94701.It was stated that during use, there was alleged backflow of medication through the checkvalve for two sets.
Additional Manufacturer Narrative
No patient complications were reported.No complaint sample has been received for investigation and no lot number was provided by the customer.Quest medical has reached out to the customer multiple times to request additional information and has not received any response.A supplemental report will be submitted if any additional information becomes available.

• Brand Name: Q2 T-EXTENSION SET
• Common Device Name: IV EXTENSION 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: 14461928
• Report Number: 1649914-2022-00008
• Device Sequence Number: 12055916
• Product Code: FPA
• UDI-Device Identifier: 00634624957015
• UDI-Public: 00634624957015
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K800825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: 95701
• Device Catalogue Number: 95701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/20/2022
• 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