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

Model Number	18875
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/07/2019
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, the patient was transferred to the icu for tracheal intubation ventilator assisted due to type ii respiratory failure, while strengthening anti-infection treatment.In the ventilation process, the ventilator intermittently indicated that there was a leak, and after the balloon was inflated it improved.Tracheal intubation was removed and the balloon was found to be severely leaking.It was reported that the treatment was extended.

• Brand Name: TAPERGUARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8857231
• Report Number: 2936999-2019-00503
• Device Sequence Number: 14168039
• Product Code: BTR
• UDI-Device Identifier: 30884521032532
• UDI-Public: 30884521032532
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 1810298JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR