MAUDE Adverse Event Report: COVIDIEN 10FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721055E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the en fit tubing was blocked at the y connector.The health care provider attempted to unclog it, re-positioned it, and it was still blocked.The tube was replaced and there was no harm to the patient.
Additional Manufacturer Narrative
There were no samples or digital images received for evaluation therefore the reported condition could not be confirmed.According to the instructions for use feeding tubes should be flushed frequently to prevent clogging.Suggested flushing schedule: a) before and after each feeding.B) before and after administering medication.C) once every four hours during continuous feeding or between intermittent feedings.D) each time the feeding set is disconnected.E) each time the feeding container is filled/changed.F) each time the pump is stopped.The root cause cannot be specifically identified therefore corrective actions will be limited to monitoring the process for any adverse trends that require immediate attention.
Additional Manufacturer Narrative
Investigation summary: a device history record review could not be performed because the lot number reported is not valid.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One decontaminated sample without the original package or lot number was received for evaluation.The returned device was evaluated, and no failures were found.The device worked as expected.The reported condition could not be confirmed.At this time, an action plan is not deemed required since the reported condition was not confirmed to be manufacturing related.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: 10FR X 55 ENTRIFLEX W/STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10396685
• Report Number: 9612030-2020-02560
• Device Sequence Number: 2743409
• Product Code: KNT
• UDI-Device Identifier: 10884521582989
• UDI-Public: 10884521582989
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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: 8884721055E
• Device Catalogue Number: 8884721055E
• Device Lot Number: 112222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020; 07/28/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/15/2020; 02/18/2021
• Patient Sequence Number: 1