MAUDE Adverse Event Report: COVIDIEN CONT. FEEDING SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884741821
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested but to date has not yet been received.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The patient's father states that his (b)(6) old daughter received a kangaroo skin level tube access - continuous right angle feeding set on (b)(6) 2019 at the children's hospital in (b)(6).Only four weeks later, the hose detached from the right-angled adapter piece.

• Brand Name: CONT. FEEDING SET
• 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: 8593337
• Report Number: 9612030-2019-02168
• Device Sequence Number: 19375547
• Product Code: KNT
• UDI-Device Identifier: 20884521023960
• UDI-Public: 20884521023960
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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: 8884741821
• Device Catalogue Number: 8884741821
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 MO