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

Model Number	18770
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2018
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, upon inflating the cuff, air leaked.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Additional information: evaluation summary: one sample was received.This product is used in treatment.A visual inspection was performed and it showed that cuff presents a small cut.An inflation and deflation test was performed to the and it was observed the cuff deflated after a few seconds.The product does not meet specification.The failure mode of cuff leaked was confirmed.The product disposition is unknown.The fault was isolated to small cut in cuff, however no root cause was determined.This failure relates to the complaint event.The record from manufacturing lot was reviewed and ensure that product was released meeting all quality release specifications at the time of manufacture.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: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7405207
• Report Number: 2936999-2018-00248
• Device Sequence Number: 13882742
• Product Code: BTR
• UDI-Device Identifier: 60884522007592
• UDI-Public: 60884522007592
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 01/18/2022
• Device Model Number: 18770
• Device Catalogue Number: 18770
• Device Lot Number: 17A0386JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1