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

Model Number 9545

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

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 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
• Type of Device: INTRAVASCULAR ADMINISTRATION 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: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7011798
• MDR Text Key: 92603676
• Report Number: 1649914-2017-00077
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 00634624095458
• UDI-Public: 00634624095458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 9545
• Device Catalogue Number: 9545
• Device Lot Number: 0502535D06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention