MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT; AIRWAY, ESOPHAGEAL (OBTURATOR)

Model Number 5-18541

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a communication regarding a combitube 41 fr tray.The customer reported that the cuff had breakage.The customer indicated there was no patient involvement with this event.

• Brand Name: MALLINCKRODT
• Type of Device: AIRWAY, ESOPHAGEAL (OBTURATOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6536039
• MDR Text Key: 74305643
• Report Number: 2936999-2017-05170
• Device Sequence Number: 1
• Product Code: CAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K875226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2018
• Device Model Number: 5-18541
• Device Catalogue Number: 5-18541
• Device Lot Number: 13I0332JZX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/02/2017
• Date Device Manufactured: 09/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1