MAUDE Adverse Event Report: COVIDIEN 20FR PEG ADAPTOR ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884752042E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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.
Event or Problem Description
The customer reported the y port adaptor leaks at the point where it connects to the funnel.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: h6 type of investigation; investigation findings; investigation conclusions.Investigation summary: one decontaminated y-port without original package or lot number was received for evaluation.After performing the visual and functional evaluations, the reported condition was confirmed.Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A review through the manufacturing process was conducted.All process and controls were found properly followed.There were no abnormal conditions found that could trigger the reported condition.The manufacturing process includes 100% visual inspection by the production personnel during the packaging process in order to detect and discard any identified failures.Based on the available information, an exact root cause could not be determined and no trend exists for the reported issue.At this time, no action plan is deemed required.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: 20FR PEG ADAPTOR ENFIT
• 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: 11941866
• Report Number: 9612030-2021-02928
• Device Sequence Number: 4226984
• Product Code: PIF
• UDI-Device Identifier: 30884521664061
• UDI-Public: 30884521664061
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/02/2021

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: 8884752042E
• Device Catalogue Number: 8884752042E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1