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

Model Number 8DCT

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 07/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the piece of the tube has dislodged.The customer reported that the patient went into state of agitation due to dislodged piece in the trachea.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the sample was received for evaluation and a visual inspection was conducted and it was observed that the flange is separated from the tube as well as it was noticed damage on both outer cannula holes which would have been detected immediately in the manufacturing process since that defect is extremely obvious; therefore, the failure mode is not confirmed as related with the manufacturing process.Additionally a dimensional test was performed to the outer cannula holes and flange lug pins and all the readings are within according to 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.

• Brand Name: SHILEY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder,co, MA 80301 ; 3035306582
• MDR Report Key: 7757237
• MDR Text Key: 116246407
• Report Number: 2936999-2018-00491
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 17F0144JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 11/08/2018
• Supplement Dates FDA Received: 10/02/2018; 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• 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
• Patient Outcome(s): Other