MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711253

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the blue tip was released from the wire/ stylet.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no.125; cuidad industrials; tijuana,na 22444 ; MX 22444
• Manufacturer (Section G): COVIDIEN; calle 9 sur no.125; cuidad industrials; tijuana,na 22444 ; MX 22444
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7641669
• MDR Text Key: 112457609
• Report Number: 9612030-2018-00111
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 703890864X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• 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