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

Model Number 8DIC

Device Problem Human-Device Interface Problem (2949)

Patient Problem Extubate (2402)

Event Date 08/13/2018

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 unit's inner cannula had a piece of round plastic in it that was blocking it.The plastic is connected in the tube and won't come out without force.The patient was recannulated.

Manufacturer Narrative

Evaluation summary: one sample was received for evaluation.A visual inspection was performed, and it was observed with a piece of plastic, the failure mode occlusion was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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 ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7828312
• MDR Text Key: 118613207
• Report Number: 2936999-2018-00547
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 60884522005321
• UDI-Public: 60884522005321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: 8DIC
• Device Catalogue Number: 8DIC
• Device Lot Number: 18D0493JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• 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): Required Intervention
• Patient Age: 48 YR