MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL FEEDING; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	UNKNOWN ENTERAL FEEDING
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it was discared; 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
The customer reported both formula and potentially stomach acid leaked on to the patient from where the luer lock type connection attaches to the g-tube.There were no burns observed.The tubing did not seem to disconnect from the luer lock port as both pieces were still intact.In addition, the customer does not have the lot number available and does not have the affected product as it was discarded.
Additional Manufacturer Narrative
The customer reported that the device involved was one of two devices.Mansfield product monitoring has attempted to gather clarification of the device product number several times ((b)(6) 2020, (b)(6) 2020,(b)(6) 2020, (b)(6) 2020, (b)(6) 2020 and (b)(6) 2020).To date, no clarification has been received.If additional information becomes available, the report will be updated.Based on the above information, the following sections have been updated: section d1, brand name updated to unknown enteral feeding set.Section d4, model number updated to unknown enteral feeding.Section d4, catalog number updated to unknown enteral feeding.Section d4, udi # updated to unknown.

• Brand Name: UNKNOWN ENTERAL FEEDING
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9611390
• Report Number: 1282497-2020-08871
• Device Sequence Number: 524113
• Product Code: KNT
• UDI-Device Identifier: 10884521002197
• UDI-Public: 10884521002197
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: UNKNOWN ENTERAL FEEDING
• Device Catalogue Number: UNKNOWN ENTERAL FEEDING
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1