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

Model Number	86113
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2017
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 during inspection prior to use on a patient, the cuff did not inflate.There was no patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: based in the complaint system and manufacturing controls, the following facts were concluded: the device history record (dhr) was not reviewed since the lot number was not provided.The sample was received for evaluation and an inflation/deflation test was performed 25cc of air was applied to the cuff using a syringe and it was observed the cuff held the air, various times the cuff was inflated and deflated with no difficulties, the sample was left inflated 2 hours according to process instruction hhp-31104 rev af, and no failure mode was observed: therefore no failure mode was observed in the received sample and all manufacturing controls were found acceptable and effective to detect the reported failure mode.Correction:(name, email).If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLINCKRODT
• 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: 7121998
• Report Number: 2936999-2017-05689
• Device Sequence Number: 16388278
• Product Code: BTR
• UDI-Device Identifier: 60884522000135
• UDI-Public: 60884522000135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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: 03/01/2022
• Device Model Number: 86113
• Device Catalogue Number: 86113
• Device Lot Number: 17C0041JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/02/2018; 02/19/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/16/2018; 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1