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

Model Number	86447
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extubate (2402); No Information (3190)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The balloon in the tube has popped during intubation.The patient required reintubation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for evaluation.The reported event was confirmed.An inflation and deflation test is performed for all products.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 event.Instructions for use (ifu) states that as these devices may have been subjected to handling, storage conditions or preparation which compromised functional integrity; each tube' cuff, pilot balloon and valve should be tested by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used.Initiating treatment using a tube already shown to have a dysfunction in the inflation system could.Various bony anatomical structures (e.G., teeth, turbinates) within the intubation routes 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 insertion which would create the need to subject the patient to the trauma of extubation and re-intubation.If the cuff is damaged, the tube should not be used.Do not overinflate cuff.Ordinarily, the cuff pressure should not exceed 25 cm h20.Maintaining a seal pressure at or below 25 cm h20.Overinflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.The device history record was reviewed and no discrepancies were found.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: 8055698
• Report Number: 2936999-2018-00678
• Device Sequence Number: 1914834
• Product Code: BTR
• UDI-Device Identifier: 10884522005739
• UDI-Public: 10884522005739
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

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: 86447
• Device Catalogue Number: 86447
• Device Lot Number: 18F0240JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018; 03/13/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 11/13/2018; 04/03/2019
• 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: Required Intervention