MAUDE Adverse Event Report: COVIDIEN 12FR 55 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461255E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been discarded; 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 that the tube broke (crack) 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.
Additional Manufacturer Narrative
The device history record (dhr) is established based on the serial number stick on the device.The serial number was not provided therefore the dhr could not be reviewed.The samples were already used on a patient, so they could not be taken to the production line for evaluation following customs policy therefore a sample evaluation is not able to be completed.A photograph depicting the affected part was not provided for evaluation.A review of the manufacturing process of the y-port assembly, test and inspection was conducted.A leak test was performed as per customer specification.There was no y-port crack/detached issue found during the last four years.Customer feedback was reviewed for the same model and, no similar issues were reported for the same model.A review of the manufacturing and quality process controls for this product was also conducted by the supplier yielding the same results therefore they unable to determine the root cause due to limited information.There are no corrective actions taken at this time.

• Brand Name: 12FR 55 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11579665
• Report Number: 1282497-2021-10010
• Device Sequence Number: 14367419
• Product Code: KNT
• UDI-Device Identifier: 20884521706160
• UDI-Public: 20884521706160
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 461255E
• Device Catalogue Number: 461255E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 06/21/2021
• Patient Sequence Number: 1