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

Model Number	7771810E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2021-02919
• Device Sequence Number: 19683006
• Product Code: PIF
• UDI-Device Identifier: 10884521582743
• UDI-Public: 10884521582743
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 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
• Operator of Device: No Information
• Device Model Number: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1