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

Model Number	86550
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
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, the device had a sticky material, shorter in length, and was easily kinked.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: three samples were taken from lot number, product part number and the overall length of each unit was measured.This confirms that each unit was found to be within the blueprint specification.Visual examination of the units inspected confirms that there are not sticky to touch with a slightly frosted finish.The reported defect could not be detected on the samples inspected.All of our reinforced products undergo a first piece inspection carried out by the machine setter and cross checked by the quality controller during this inspection the material part number and lot number is checked and recorded on the batch record.Post second extrusion each unit is 100% inspected it is at these stages of the process that any defect is identified and removed from the lot.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7886439
• Report Number: 8020889-2018-00088
• Device Sequence Number: 16626274
• Product Code: BTR
• UDI-Device Identifier: 10884522043359
• UDI-Public: 10884522043359
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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 Model Number: 86550
• Device Catalogue Number: 86550
• Device Lot Number: 73F1800548
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1