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

Model Number	125037
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/02/2017
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
Medtronic received a communication regarding a cuff that could not be deflated.The customer indicated that there was no patient involvement as the issue was found while checking prior to use.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation contained in its original unit carton also contained in the carton is its original opened unit pack.Visual examination shows no sign of any defect.The stylet wire was not returned with this unit.The returned unit was inflated using the parameters set out in if001.The returned unit inflated/deflated without any issue.The returned unit was inflated/deflated three times without any restriction noted.The most probable root cause is the end user did not fully depress the inflation valve during the deflation process.All of our product under goes a four hour inflate/deflate and it is at this stage of the process that any defects are removed from the lot.The reported defect could not be detected on the unit returned for evaluation.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: 7039334
• Report Number: 8020889-2017-05183
• Device Sequence Number: 19064106
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 11/01/2021
• Device Model Number: 125037
• Device Catalogue Number: 125037
• Device Lot Number: 201611524X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1