MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4.0PDC
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that prior to use on a patient, the obturator was difficult to insert through the tube.The tube was eventually inserted.The customer indicated that there was no patient involvement.
Additional Manufacturer Narrative
One sample of pediatric tracheostomy tube part number 4.0pdc was received for evaluation.Visual examination performed confirmed all the components are assembled properly.Functional testing was performed by inserting an obturator into the cannula and no obstruction or difficulties were detected during the test.No ridges were observed in the inner diameter of the cannula and no failure mode was observed in the received sample.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that prior to use on a patient, the obturator was difficult to insert through the tube.The tube was eventually inserted.The customer indicated that there was no patient involvement.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,mex 32590 ; MX 32590
• MDR Report Key: 6828289
• Report Number: 2936999-2017-05431
• Device Sequence Number: 16158149
• Product Code: JOH
• UDI-Device Identifier: 20884522029107
• UDI-Public: 20884522029107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: 09/07/2021
• Device Model Number: 4.0PDC
• Device Catalogue Number: 4.0PDC
• Device Lot Number: 16I0161JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1