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

Model Number	3.5PED
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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, when the cannula band was replaced a crack was found on the left fixing strap site.There was no patient injury.
Additional Manufacturer Narrative
Product analysis #245486385:sample analysis: one sample of pediatric tracheostomy tube part number 3.5ped was received for evaluation, lot number provided by gch is 18h0046jzx, the received components are one cannula and one size 3.5 ped obturator, a visual inspection was performed and it was observed the flange eyelet is broken, the failure mode flange eyelet breakage is confirmed on (b)(6) 2019.Completed y (b)(6) on (b)(6) 2019.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: 8714767
• Report Number: 2936999-2019-00416
• Device Sequence Number: 16602058
• Product Code: JOH
• UDI-Device Identifier: 30884522026707
• UDI-Public: 30884522026707
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945513
• 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): 08/30/2019

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: 08/02/2023
• Device Model Number: 3.5PED
• Device Catalogue Number: 3.5PED
• Device Lot Number: 18H0046JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1