MAUDE Adverse Event Report: MALLINCKRODT; AIRWAY, ESOPHAGEAL (OBTURATOR)

Model Number	5-18437
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, when the unit was taken out of the box and inflated, the main balloon was noted to leak and had a small hole in it.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The failure tear in cuff was confirmed in the received sample.Device history record was not reviewed since the lot number was not provided.Manufacturing process was reviewed and currently, there is not any potential risk and the below condition was found.Describe the guidelines to have a resting time of 4 hours with inflated cuffs and then the parts are inspected for proper inflated cuffs.All manufacturing controls were found acceptable and effective to detect the reported failure mode.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.
Event or Problem Description
According to the reporter, when the unit was taken out of the box and inflated, the main balloon was noted to leak and had a small hole in it.There was no patient involvement.

• Brand Name: MALLINCKRODT
• Common Device Name: AIRWAY, ESOPHAGEAL (OBTURATOR)
• MDR Report Key: 7503496
• Report Number: 2936999-2018-00336
• Device Sequence Number: 19210620
• Product Code: CAO
• UDI-Device Identifier: 10884521211957
• UDI-Public: 10884521211957
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K875226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5-18437
• Device Catalogue Number: 5-18437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 10/18/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention