MAUDE Adverse Event Report: COVIDIEN 18FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771810E

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/13/2021

Event Type  malfunction  

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the icu manager was moving a patient and the purple port broke off causing the syringe to fall off in the bed.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.Two decontaminated components; a 60ml syringe and a gientry enfit port without its original packaging or a printed lot number were received for evaluation.The sample was reviewed for specification requirements and the condition reported by the customer was confirmed however this condition was not caused at the manufacturing facility.During the investigation an attempt was made to replicate the reported condition, at the time that the assembly between the syringe and gentri was dropped, and the issue was replicated.The case was reviewed with the multifunctional team.All process and controls were found properly followed, including sub-assemblies, finished product.There were no abnormal conditions found that could trigger the reported condition; and the condition has not been reported to be present in the past and the current process was running according to approved specifications.The possible root cause for the condition was that it occurred when moving or adjusting the product during use.The condition reported by the customer was not confirmed to be manufacturing related therefore, corrective actions are not required at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: 18FR SALEM W/ GIENTRI PORT WIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11885552
• MDR Text Key: 252717036
• Report Number: 9612030-2021-02919
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582743
• UDI-Public: 10884521582743
• 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: 07/23/2021

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
• Device Operator: No Information
• Device Model Number: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 07/23/2021
• Patient Sequence Number: 1