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

Model Number	5.5PDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
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 device's cannula flange was tore easily.The customer indicated no patient harm.
Additional Manufacturer Narrative
Evaluation summary: six devices were received for evaluation.The reported event was confirmed.A visual inspection was performed and it was observed each one of cannulas presented a broken eyelet.The device history record (dhr) was reviewed and no discrepancies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7571135
• Report Number: 2936999-2018-00372
• Device Sequence Number: 2514929
• Product Code: JOH
• UDI-Device Identifier: 20884522026731
• UDI-Public: 20884522026731
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 10/01/2018
• Device Model Number: 5.5PDL
• Device Catalogue Number: 5.5PDL
• Device Lot Number: 13J0616JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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