MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 CHECKMATE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	9545
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The hospital reported an issue encountered with the intravenous administration extension set during use.The report stated that some of the luer locks do not appear to have a fixed stopping point- like they have been stripped out.The report stated that as a result the infusion sets would then come off of the manifold during the procedures, causing a delay in the procedure while the issue was remedied.The complainant reported that out of (b)(4) eaches in a box of the product they have had issues with at least (b)(4) of the devices.A complaint sample has been returned to the manufacturer for analysis.There were no patient complications reported as a result of the alleged event.
Additional Manufacturer Narrative
Visual examination of the complaint sample found that the tubing from the checkmate component appears to have been removed and re-configured by the customer.The cap on the checkmate rotated as if it did not have any threads.Further examination found that the threads appeared distorted either from over-tightening or by repeated threading onto other ports.It is likely the luer on non-quest tubing could have distorted the hub threading.The device history record for the lot and subcomponent lot(s) were reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: Q2 CHECKMATE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5865131
• Report Number: 1649914-2016-00039
• Device Sequence Number: 18950860
• Product Code: FPK
• UDI-Device Identifier: 00634624095458
• UDI-Public: 00634624095458
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K800825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2016

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: Nurse
• Device Expiration Date: 12/08/2018
• Device Model Number: 9545
• Device Lot Number: 0502535D06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention