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

Model Number MCFN

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a communication regarding two custom tracheostomy tubes alleged to be made incorrectly.The customer alleged that the tubes did not have the bend in the flange as directed by the custom-tube prescription.No patient harm was reported.

• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6975328
• MDR Text Key: 90754469
• Report Number: 2936999-2017-05571
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2018
• Device Model Number: MCFN
• Device Catalogue Number: MCFN
• Device Lot Number: 13F0604JZX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2017
• Date Device Manufactured: 06/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1