MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the entriflex connector was stripped and came apart (when trying to disconnect the feeding set from the feeding tube).This required replacement of the feeding tube.The connector did not break, rather it seemed like an adhesive failed possibly.When they implemented these tubes, a key piece of education was not to overtighten and the staff were aware of this.Per additional information received, the plastic tip of the entriflex tube came apart (i.E., stripped) from the entriflex connector rendering the tube unusable.There was no medical intervention required besides tube replacement.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on june 14, 2022.The investigation was carried out with the multifunctional team, all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.There were no physical samples received for the investigation.A photo was provided but based on a visual inspection, no damage was observed from the photo.Without a physical sample, we are unable to confirm the reported condition or determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.We will continue to monitor for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16278323
• MDR Text Key: 308748528
• Report Number: 9612030-2023-03542
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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 Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2216003664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1