MAUDE Adverse Event Report: COVIDIEN GIENTRI PORT WITH ENFIT CONNEC; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	771111E
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	05/21/2021
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 purple enfit port broke off while a nurse was screwing the syringe on to flush medications.There was no patient harm.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot 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 decontaminated sample was received at the manufacturing site for the investigation.The sample arrived without the original package or lot number.Sample analysis was performed.As part of the analysis, the sample was visually inspected and the enfit connector was observed to be broken; part of the purple connector separated from the blue body.The case was reviewed with the multifunctional team.All process and controls were found properly followed, including sub-assemblies and finished product.There were no abnormal conditions found that could trigger the reported condition.In addition, the condition has not been reported to be present in the past and the current process is running according to approved specifications.During the investigation and with the intention of reproducing the reported issue, two conditions were evaluated: a sample from the current process was used, to which a 60ml syringe was connected to simulate use; the syringe was connected and disconnected several times trying to turn the assembly in an exaggerated way, but the reported condition was not reproduced.Another sample was used, to which a 60ml syringe was placed on and it was dropped from a height of approximately 36".In this simulation, the reported issue was reproduced.Based on all available information, a definitive root cause could not be determined at this time.However, the most probable root cause was determined to be user misuse as the reported condition does not appear to be manufacturing related.As a result, corrective action will be limited to manufacturing awareness at this time.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: GIENTRI PORT WITH ENFIT CONNEC
• 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: 11941314
• Report Number: 9612030-2021-02927
• Device Sequence Number: 17200335
• Product Code: PIF
• UDI-Device Identifier: 10884521582750
• UDI-Public: 10884521582750
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/21/2021

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: 771111E
• Device Catalogue Number: 771111E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1