MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 INTRAVENOUS ADMINISTRATION SET; IV ADMINISTRATION SET

Model Number	9527B
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
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 hospital reported an issue with the intravenous administration set.The nurse reported that the set was connected to a patient for chemotherapy, but on day 3 as the nurse was disconnecting the line the blue port detached from the set's manifold.There was no patient information provided.The lot number of the device was not provided.There were no patient complications reported as a result of the alleged event.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The device was returned without the portion of the device (the cap) that had allegedly broken off during use.Visual examination of the returned portion found there were remnants of the welding all around the edges of the port.The device had originated from a possibility of 3 different lots.Dhrs for those 3 lots were reviewed and none were found to have anomalies or defects related to the reported complaint condition.Process review verified the proper manufacturing controls, including side load force testing, were in place.

• Brand Name: Q2 INTRAVENOUS ADMINISTRATION SET
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6292852
• Report Number: 1649914-2017-00002
• Device Sequence Number: 1102603
• Product Code: FPA
• UDI-Device Identifier: 00634624952720
• UDI-Public: 00634624952720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: Nurse
• Device Model Number: 9527B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 02/07/2017
• 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