MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 24FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	724200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional 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. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the patient was in decubitus dorsal position, infusing artisanal diet as usual and the parent noticed intense leakage, when he looked at the balloon, it was already slightly externalized.The nursing technician on duty also saw it and when they picked up the balloon, they saw it was leaking due to spontaneous rupture of the cuff.Additional information received from the customer stated that the probe was loose, allowing the leak of the diet through the ostomy.There was no patient harm reported.

• Brand Name: BALLOON SLG 24FR X 2.0CM
• 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: 10206297
• Report Number: 9612030-2020-02511
• Device Sequence Number: 2613596
• Product Code: KNT
• UDI-Device Identifier: 10884521011410
• UDI-Public: 10884521011410
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/29/2020

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: No Information
• Device Model Number: 724200
• Device Catalogue Number: 724200
• Device Lot Number: 1918335164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1