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

Model Number	86232
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	07/01/2020
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, an infant was intubated in deliver room.When the infant was placed on the warmer bed, the vital sign deteriorated.When checked the device placement, it was in the esophagus.The tube was pulled, patient was bagged and new tube was placed.When turning the patient in bed after taping the tube, it was found the tube was split.The tube was trimmed to prevent further splitting and attached to the jet with great difficulty.The tube kept disconnecting from the vent overnight so patient was re-intubated the following day.

• Brand Name: SHILEY
• 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: 10535912
• Report Number: 9681384-2020-00018
• Device Sequence Number: 3394944
• Product Code: BTR
• UDI-Device Identifier: 10884521620230
• UDI-Public: 10884521620230
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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 Expiration Date: 10/31/2024
• Device Model Number: 86232
• Device Catalogue Number: 86232
• Device Lot Number: 19K0209JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2020
• 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: 1 DA