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

Model Number	125037
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/30/2018
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, prior to use, the device had air leak from tracheal cuff upon cuff check.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.An attempt made to inflate the returned unit using the parameters set out shows the bronchial cuff inflated without any issue but the tracheal cuff failed to inflate.The returned sample was leak tested under water and leakage was detected from the tracheal cuff body but no leakage was detected from the bronchial cuff.The bronchial cuff deflated and no issue noted.Further examination of the tracheal cuff shows two cuts to the cuff body.This type of damage is indicative of the tracheal cuff coming in contact with a sharp utensil or object.The single wall thickness of the cuff was measured away from the damaged area and found to meet the blueprint specifications.The reported defect could be detected on the returned sample.All of our bronchocath products undergo a four hour inflate/deflate test and it is at this stage of the process that any defects are removed.We would like to draw your attention to our instructions for use (ifu) where the following is stated ¿ various bony anatomical structures (e.G., teeth) within the intubation route or any intubation tools with sharp surfaces present a threat to maintaining cuff integrity.Care must be taken to avoid damaging the thin-walled cuffs during intubation which would create the need to subject the patient to the trauma of extubation and re-intubation.If either cuff is damaged, the tube should not be used.¿ 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: 8200068
• Report Number: 8020889-2018-00140
• Device Sequence Number: 19353097
• Product Code: BTS
• UDI-Device Identifier: 30884522008741
• UDI-Public: 30884522008741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 05/01/2023
• Device Model Number: 125037
• Device Catalogue Number: 125037
• Device Lot Number: 201805241X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1