MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)

Model Number	125028
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the fiber on tubing lumen side seemed to be stuck in.The facility operate hyperhidrosis surgery with the product more than 10 par month.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation contained in a plastic bag without its original unit pack.Visual examination shows no sign of any defect.The occlusion test was carried out on the returned unit.The tip of the rod must pass through the y-adaptor for a minimum distance of 1cm.The rod passed freely through the y-adaptor and tubing.This confirms that there was no occlusion present on the unit returned for evaluation.The most probable root cause is the cuff body came in contact with a sharp utensil or object.The most probable root cause is the end user use a scope with a diameter which was not compatible with the diameter of our tubing.All of our product undergo a 100% occlusion test during the manufacturing process.It is at this stage process that occlusions/blockages in the main stem of the tubing are identified and removed from the lot.The reported defect could not be detected on the unit returned for evaluation.The device failed to meet specification as it was received or made available for evaluation.The cause of the observed condition was determined to be cuff body came in contact with a sharp utensil or object.The product relates to the reported complaint event.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7669469
• Report Number: 8020889-2018-00067
• Device Sequence Number: 849118
• Product Code: BTS
• UDI-Device Identifier: 40884522008717
• UDI-Public: 40884522008717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K854547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

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 Expiration Date: 06/01/2022
• Device Model Number: 125028
• Device Catalogue Number: 125028
• Device Lot Number: 201706036X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 01/29/2019
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/03/2018; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1