MAUDE Adverse Event Report: MMJ, S.A. DE C.V. TAPERGUARD; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18785S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2018
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 could not be injected with air at the time of the leak test.A second attempt also failed.Air could be injected on the third attempt but new tube was opened.The customer indicated there was no patient involved in this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: (return date).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: (udi#).Evaluation summary: one sample was received for analysis and the reported issue could not be confirmed.An inflation/deflation test was performed the syringe was connected to the valve and it was observed the cuff could be inflated and deflated and no restriction was observed, the sample was left inflated 2 hours according to process instruction and after this time no deflation was observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TAPERGUARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ, S.A. DE C.V.; ave. henequen no 1181 desarrol; ciudad juarez,ci MX
• MDR Report Key: 7334149
• Report Number: 2936999-2018-00157
• Device Sequence Number: 638590
• Product Code: BTR
• UDI-Device Identifier: 20884521620213
• UDI-Public: 20884521620213
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/31/2018

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: 10/02/2022
• Device Model Number: 18785S
• Device Catalogue Number: 18785S
• Device Lot Number: 17J0110JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/10/2018; 05/03/2018; 08/01/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/26/2018; 05/23/2018; 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1