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

Model Number	86222
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	06/13/2018
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
According to the reporter, during use, the device had physical damaged.It was reported that the tube became soft excessively after 24 hours of having placed in the patient.The patient began to desaturate because the tube collapsed and the tube light was closed.The physician decided to cut the tube at the section that was collapsed but then the tube collapsed again in the new section.The physician decided to re-intubate the patient.It was indicated that the tube became soft because of the heat in the incubator but claimed that the package of the tube did not indicate the maximum temperature in which the tube can be exposed.

• 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: 7645899
• Report Number: 2936999-2018-00421
• Device Sequence Number: 1638427
• Product Code: BTR
• UDI-Device Identifier: 50884522005751
• UDI-Public: 50884522005751
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: 86222
• Device Catalogue Number: 86222
• Device Lot Number: 17K0718JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/28/2018
• 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: Required Intervention
• Patient Age: 23 DA