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

Model Number	125032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2019
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 two devices' cuff was found damaged when examined before intubation.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation in a sample bag along with the device and the opti port assemblies contained in their unopened unit packs.Visual examination of the returned sample shows the shape of the tubing has been severely altered.The most probable root cause is an inflation device remained in the inflation valve allowing the air to escape.Further examination shows no sign of any defect.The returned unit was inflated using the parameters set out in if001.Both cuffs on the returned unit inflated without any issue.The returned unit was leak tested under water and no leakage was noted.The returned unit remained inflated for a four-hour period and no issue noted.The reported defect could not be detected on the unit returned for evaluation.All of our products undergo a four hour inflate / deflate test and it is at this stage of the process any defects are removed from the lot.Please refer to our ¿instructions for use¿ under the section warnings / precaution (cuff-related): where it states ¿syringes, three-way stopcocks or other luer tip devices should not be left inserted in the inflation valves for extended periods of time¿.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: 9079924
• Report Number: 8020889-2019-00118
• Device Sequence Number: 2529706
• Product Code: BTS
• UDI-Device Identifier: 30884522028961
• UDI-Public: 30884522028961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 04/01/2020
• Device Model Number: 125032
• Device Catalogue Number: 125032
• Device Lot Number: 201504336X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1