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

Model Number 461255E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discomfort (2330)

Event Type  malfunction  

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 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.

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 461255e.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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11579793
• MDR Text Key: 243365036
• Report Number: 1282497-2021-10012
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521706160
• UDI-Public: 20884521706160
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 461255E
• Device Catalogue Number: 461255E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 06/21/2021
• Patient Sequence Number: 1