MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 MULTIPORT EXTENSION SET, 10 INCH; INTRAVASCULAR ADMINSTRATION AND EXTENSION SETS

Model Number	9520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant/initial reporter did not know the lot number of the affected product.They reported that they had 5 lots of the relevant product code on hand, which are: 050323, 050069, 050433, 050676, 050776 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 risk manager reported an issue encountered with the device during use.The report stated that the patient had undergone a coronary artery bypass and was in the surgical intensive care unit (sicu).Two days after the procedure the nurse caring for the patient noticed that one port of the administration manifold had come off and that medication was dripping onto the floor.The report listed the medication as amiodarone.The report stated the nurse corrected the problem.There were no patient or provider complications reported as a result of the alleged event.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual examination found that the device met all manufacturing specifications.Destructive testing of the cap welds found sufficient welds were present at all cap weld locations.The exact lot number of the affected device was not provided; however, distribution records were available to identify 5 potential lots of product.Review of the applicable device history records found no anomalies and no manufacturing issues related to the reported complaint.It is possible the reported complaint was due to mishandling or damage to the device while in use by the end user.

• Brand Name: Q2 MULTIPORT EXTENSION SET, 10 INCH
• Common Device Name: INTRAVASCULAR ADMINSTRATION AND EXTENSION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5703466
• Report Number: 1649914-2016-00025
• Device Sequence Number: 13523171
• Product Code: FPA
• UDI-Device Identifier: 00634624952003
• UDI-Public: 00634624952003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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?: No
• Operator of Device: Nurse
• Device Model Number: 9520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 07/01/2016
• 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
• Patient Age: 76 YR
• Patient Weight: 100