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

Model Number	18885
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2019
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 unit's tube and the connector part were easy to get disconnected, so another tube was used.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The reported event could be confirmed.A dimensional test was performed mark of insertion of the connector, inner diameter of the tube and the received connector, this reading is within specification.The connector is not the correct size and is easy to come off.Formal investigation was initiated to address the incorrect connector issue.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
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8652510
• Report Number: 2936999-2019-00376
• Device Sequence Number: 2359297
• Product Code: BTR
• UDI-Device Identifier: 30884521032556
• UDI-Public: 30884521032556
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 11/09/2019
• Device Model Number: 18885
• Device Catalogue Number: 18885
• Device Lot Number: 14K0216JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1