MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 T CONNECTOR EXTENSION SET W/ Q2 T-SITE-CHECKVALVE, MICROBORE TUB; FLUID DELIVERY EXTENSION SET

Model Number	95701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.The inventory on the device lot is depleted and an investigation could not be carried out on a device from the same lot.A dhr review was conducted and there were no non-conformities or deviations associated with the manufacturing of this device.The review showed no anomalies.A complaint history review for the last 24 months was also conducted and no similar issues were found.The root cause of the reported issue is unknown.
Event or Problem Description
The product distributor reported an issue encountered by their customer when using the fluid delivery extension set.The report stated that a piece of the device broke off during delivery of anesthesia to a patient during a cataract procedure.They reported that the furthest port, the one at the 180 degree angle, is the one that completely disconnected from the rest of the tubing and that the extension that sits at a 90 degree angle to the main tubing was intact.They reported the break was very clean with n apparent mishandling or severe damage to the unit.There were no patient complications reported as a result of the alleged issue.The device was discarded by the customer and not returned for evaluation.

• Brand Name: Q2 T CONNECTOR EXTENSION SET W/ Q2 T-SITE-CHECKVALVE, MICROBORE TUB
• Common Device Name: FLUID DELIVERY EXTENSION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 7011813
• Report Number: 1649914-2017-00072
• Device Sequence Number: 497652
• Product Code: FPK
• UDI-Device Identifier: 00634624957015
• UDI-Public: 00634624957015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: Health Professional
• Device Model Number: 95701
• Device Catalogue Number: 95701
• Device Lot Number: 0531267M05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 11/08/2017
• 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