MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 3.5 FR X 12; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461355
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
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 customer states that the nurse inserted a nasal gastric feeding tube and secured it with tegaderm to the patient's face.The next morning the extension tubing was still attached to the hub, but the hub was not attached to the ng tubing.The ng tubing remained secured with tegaderm to patient's face.The ng tubing was removed intact without the hub.The tube was removed just as it normally would be as if the hub was still attached.All pieces recovered.The patient tolerated it well.
Additional Manufacturer Narrative
One decontaminated sample outside of its original package without a lot number and one unused sample with lot number 1900925964 was received for evaluation.After performing a visual inspection based on the product¿s specification, only in one sample confirmed the reported condition; the purple connector was separated.The second sample arrived assembled and passed the stress test.The device history record (dhr) files were reviewed and no discrepancy was found that could attribute to the condition reported.The associated data will be fed into the risk management quarterly report.As part of continuous improvements, a formal corrective/preventative action (capa) has been opened to further investigate this report and to implement effective solutions to prevent reoccurrence of this issue.

• Brand Name: POLYUR FEED TUBE 3.5 FR X 12
• 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: 8744606
• Report Number: 9612030-2019-02209
• Device Sequence Number: 19217680
• Product Code: KNT
• UDI-Device Identifier: 10884521067394
• UDI-Public: 10884521067394
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 461355
• Device Catalogue Number: 461355
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1