MAUDE Adverse Event Report: MMJ SA DE CV(USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	86113
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199); Extubate (2402)
Type of Reportable Event	Death
Additional Manufacturer Narrative
F information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device's box was checked and there was a physical defect before opening.It was indicated that the cuff burst while in use in the patient.There was no patient injury.
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 device's box was checked and there was a physical defect before opening.It was indicated that the cuff burst while in use in the patient.A customer reported that the around 3 minutes after using, they noticed that the patient was not responding and that the cuff did not inflate.It was also reported that they tried to inflate the cuff, but it would not hold air.A customer reported that the patient was reintubated with the same size tracheostomy and neither intubation was extremely difficult and the patient expired a short time later.
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 reviewed and no discrepancies were found.Manufacturing process was reviewed and currently, there is no potential risk and the below conditions were found: an inflation test is performed for all products.All products have a resting time of 2 hours.Deflation test is performed for all products.The operator inspects for no leaks and segregates the defective parts.Once the part is inspected visually, then the instruction provides the guidelines to deflate the cuff.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.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7850693
• Report Number: 2936999-2018-00566
• Device Sequence Number: 1337737
• Product Code: BTR
• UDI-Device Identifier: 40884522000131
• UDI-Public: 40884522000131
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2018

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: 86113
• Device Catalogue Number: 86113
• Device Lot Number: 17K0837LZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 11/06/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 09/26/2018; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death