MAUDE Adverse Event Report: COVIDIEN 10FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461055E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 was severed somehow, no one knows how.The feeding tube was clamped off with hemostats only to stop the leak.Additional information provided stated that the device was severed just below the grey y ports.It was completely separated in two different pieces.It is not known how long the device was in use prior to the incident.The device was found to be severed when staff was attempting to transfer the patient back to their bed.No patient injury although the patient noted there was a tug and he didn¿t know what happened.The device was removed and replaced.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because there was no serial number provided by the customer.The device was already used on patient therefore it could not be taken to production line for evaluation following customs policy; the product evaluation is not able to be performed.The photo of the device confirms that the tube was cut off by something; a cutting edge could be observed.The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records, including assembly, test, inspection and packaging, no risk cause y port detach.All tubes have been 100% tested by leak test station follow customer specification of air pressure 20psi.Any of leakage issue could be detected if y port detached.All tubes have been 100% inspected before packaging.Based on the investigation, the broken tube was cut off by something at the customer site.This issue was not a production related issue.The root cause could not be determined due to limited information.No corrective actions are required at this time.

• Brand Name: 10FR 55 IRIS FEEDING TUBE ENF
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11941030
• Report Number: 1282497-2021-10240
• Device Sequence Number: 11819006
• Product Code: PIF
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1