MAUDE Adverse Event Report: COVIDIEN 12 FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721255
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device may 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.
Event or Problem Description
Customer reports: the device fractured inside the patient.The stem was broken.

• Brand Name: 12 FR X 55 ENTRIFLEX W/STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10425526
• Report Number: 9612030-2020-02578
• Device Sequence Number: 2670901
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8884721255
• Device Catalogue Number: 8884721255
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other