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

Model Number	18785S
Medical Device Problem Codes	Inflation Problem (1310); Contamination of Device Ingredient or Reagent (2901)
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 prior to use on a patient, foreign material like vinyl polymers were found inside the package before opening.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: (mfr contact first name, last name and email address), (phone #).Evaluation summary one sample was received for analysis.Product was used in treatment.Visual inspection showed the presence of a loose foreign object a piece of plastic inside the pouch.The sample was received sealed inside its pouch.Product does not meet specification.The failure mode foreign object was confirmed in the provided sample.Failure was isolated to loose foreign object inside the package, however root cause was not determined.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: 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 32590 ; MX 32590
• MDR Report Key: 7235551
• Report Number: 2936999-2018-00051
• Device Sequence Number: 13486593
• Product Code: BTR
• UDI-Device Identifier: 20884521164557
• UDI-Public: 20884521164557
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: 10/31/2021
• Device Model Number: 18785S
• Device Catalogue Number: 18785S
• Device Lot Number: 16K0035JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1