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

Model Number	86224
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/08/2019
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, at the time of delivery of the input, the device was separated from the adapter which makes it no longer work.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The sample was received sealed inside its pouch.A visual inspection was performed and it was observed the 15mm connector is broken.A dimensional test was performed and no difficulty was observed at the time of insertion nor extraction, and this is within specification.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.
Event or Problem Description
According to the reporter, at the time of delivery of the input, the device was separated from the adapter which makes it no longer work.The failure was noted before it was used in patient and it was not used in a patient.The issue was happened during dispensation from pharmacy, thus there was no patient involvement.

• 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: 8638648
• Report Number: 2936999-2019-00370
• Device Sequence Number: 2211297
• Product Code: BTR
• UDI-Device Identifier: 40884522005778
• UDI-Public: 40884522005778
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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 Expiration Date: 11/29/2021
• Device Model Number: 86224
• Device Catalogue Number: 86224
• Device Lot Number: 16K0990JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1