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

Model Number	461243E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Discomfort (2330)
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 stuck.The rn tried to get it unstuck and the purple hub broke, it either cracked or fully detached.There was some leakage of either tube feedings or meds.There was no harm done to the patient but the feeding tube needed to be reinserted and the patient did experience discomfort.No further information is available.
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 customs policies.As a result, photos were instead taken of the sample by the decontamination lab and provided to the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue was confirmed; a detached component was observed.The manufacturing process of the y-port assembly, test, and inspection was reviewed and found that all tubes have been 100% tested and inspected.Tubes that fail at any station are not packaged.A leak station detects any y-port assembly issues such as breaks and leaks, but no assembly issues have been found over the past 12 months.An fni station pulls and inspects the y-port assembly quality but no y-port cracks have been found during the manufacturing process.In addition, the same failure could not be observed on raw components.Based on all available information 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: 11276774
• Report Number: 1282497-2021-09884
• Device Sequence Number: 14131332
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 02/01/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1