MAUDE Adverse Event Report: COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461243E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/01/2021
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 reported that the feeding tube broke at the y-port and the purple port coming right off.Additional information was received from the customer stated that the tube broke off at the purple cap connection and can¿t be reconnected.There was leaking observed when the feeding tube flushed after giving medication and with tube feeding running.No patient harm reported other than discomfort and inconvenience of replacing the feeding tube earlier than necessary.The feeding tube was placed on (b)(6) 2021.
Additional Manufacturer Narrative
A device history record review could not be performed because the serial number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received at our decontamination lab.However, at this time the used sample cannot be forwarded to the manufacturing site for physical evaluation due to current covid 19 customs policies.As a result, the photo the customer provided along with photos taken by our decontamination lab of the received sample were shared with the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue was confirmed; a detached component was observed.The root cause could not be determined based on the photo evaluation alone.However, if additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.As part of continuous improvements, a corrective action has been opened to address detached components.A new solvent dispenser was implemented for a better handling of the solvent during the assembly process of the y-port.

• Brand Name: 12FR 43 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11553215
• Report Number: 1282497-2021-09987
• Device Sequence Number: 4204231
• Product Code: KNT
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 461243E
• Device Catalogue Number: 461243E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1