MAUDE Adverse Event Report: MMJ, S.A. DE C.V. MALLINCKRODT; AIRWAY, ESOPHAGEAL (OBTURATOR)

Model Number 5-18437

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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 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
• Type of Device: AIRWAY, ESOPHAGEAL (OBTURATOR)
• Manufacturer (Section D): MMJ, S.A. DE C.V.; ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7503496
• MDR Text Key: 107887026
• Report Number: 2936999-2018-00336
• Device Sequence Number: 1
• Product Code: CAO
• UDI-Device Identifier: 10884521211957
• UDI-Public: 10884521211957
• Combination Product (y/n): N
• PMA/PMN Number: K875226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention