MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 CHECKMATE EXTENSION SET 44 INCH.; INTRAVASCULAR ADMINISTRATION EXTENSION SET

Model Number	9541
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
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 nurse reported an issue occurred with the iv administration extension set during use.She stated the set leaked during use.Follow-up with the complainant found that the tubing was loose and the connector kept rotating; it was not tightening.The report stated the patient was hiv positive and the leak resulted in a large amount of blood on the floor.The lot number was not provided.The device was discarded by the hospital and will not return for evaluation.Additional follow-up attempts have not been successful.

• Brand Name: Q2 CHECKMATE EXTENSION SET 44 INCH.
• Common Device Name: INTRAVASCULAR ADMINISTRATION EXTENSION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6368206
• Report Number: 1649914-2017-00014
• Device Sequence Number: 1251680
• Product Code: FPK
• UDI-Device Identifier: 00634624095410
• UDI-Public: 00634624095410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K800825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 9541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 03/01/2017
• 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