MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 EXTENSION SET, 17 INCH; INTRAVASCULAR ADMINISTRATION SET

Model Number 95902

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, no patient information was provided.The device was discarded by the customer and the lot number was not provided.A review of the device history record could therefore not be conducted.A review of the complaint and non-conformance records for this product code in the last 24 months was conducted and no similar issue was identified.The manufacturing process for this product line was also reviewed and no quality issues were identified.Quest medical has implemented several internal quality controls to ensure only conforming products are shipped out including but not limited to in-process inspection, final inspection and a dhr review prior to product release.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

Report received states that chemo leaked from below filter where the tubing is bonded to the filter.The medication being infused was etoposide.There were no patient complications resulting from the alleged issue.

• Brand Name: Q2 EXTENSION SET, 17 INCH
• 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: 6970841
• MDR Text Key: 90771741
• Report Number: 1649914-2017-00080
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151079
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 95902
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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