MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461043E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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 the kangaroo iris tube cracked at the soft rubber hub where med port & feeding port connect together.This caused a small amount of leaking from the tube.There was no harm to the patient.

Manufacturer Narrative

A device history record could not able to be reviewed as lot number was not provided.The sample was not provided for evaluation therefore the reported condition could not be confirmed.A photograph was submitted for evaluation.Based on the digital image it is possible to confirm the reported condition; the y-port is damaged.The physical sample is needed to assess the reported condition and thus determine the potential root cause.According to supplier, the y-ports are assembled prior to the air leak test.All tubes are 100% tested for air leaks prior to releasing the lot.A crack/leak issue would be detected during the air leak test.The supplier reviewed the accuracy of the air leak test station and the yield was 99.38% in past 12 months.No abnormalities were found related to the production process.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10350474
• MDR Text Key: 201404796
• Report Number: 1282497-2020-09249
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 09/23/2020
• Patient Sequence Number: 1