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

Model Number 9541

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem Blood Loss (2597)

Event Date 02/01/2017

Event Type  Injury  

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 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.
• Type of Device: INTRAVASCULAR ADMINISTRATION EXTENSION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 6368206
• MDR Text Key: 68748916
• Report Number: 1649914-2017-00014
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 00634624095410
• UDI-Public: 00634624095410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Model Number: 9541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention