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

Model Number	9545
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no patient complications associated with the alleged issue.The device was not returned for evaluation.A similar product which undergoes the same manufacturing process as the product complained about was evaluated and no leakage was observed.Dhr review conducted did not identify any manufacturing issues.The root cause of the alleged defect is unknown.
Event or Problem Description
The hospital reported an issue encountered with the intravenous administration extension set during use.The report stated that when they tighten the spin connector on the device it keeps turning and "strips" causing product to leak; it has happened on multiple occasions.There were no patient complications reported as a result of the alleged event.The device was not returned for evaluation.

• 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: 7011798
• Report Number: 1649914-2017-00077
• Device Sequence Number: 10999053
• 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: K162304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: Physician
• Device Model Number: 9545
• Device Catalogue Number: 9545
• Device Lot Number: 0502535D06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 11/08/2017
• 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