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

Model Number	461243E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/15/2021
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 tube broke at y junction.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, the used sample could not be forwarded to the manufacturing site for physical evaluation due to current covid-19 customs policies.As a result, photos were taken of the sample by the decontamination lab and provided to the manufacturing site in addition to the photo provided by the customer to aid the investigation.Upon a visual evaluation of the photos, the reported issue was confirmed; a break was observed at the y-port junction.The manufacturing process was reviewed and in general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.In addition, quality control inspections were performed to the product for material release and a 100% visual inspection was performed by production personnel during the packaging process, to detect and discard any identified issues.Based on all available information and the photo evaluation, the root cause could not be determined at this time.However, if additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• 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: 11552817
• Report Number: 1282497-2021-09986
• Device Sequence Number: 4204230
• 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,user f
• Initial Reporter Occupation: Nurse Practitioner
• 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