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

Model Number 8884752042E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/03/2021

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.

Event Description

The customer reported the y port adaptor leaks at the point where it connects to the funnel.No patient injury was reported.

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
• 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: 11941866
• MDR Text Key: 255108866
• Report Number: 9612030-2021-02928
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 30884521664061
• UDI-Public: 30884521664061
• 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: 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
• Device Operator: No Information
• Device Model Number: 8884752042E
• Device Catalogue Number: 8884752042E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 09/02/2021
• Patient Sequence Number: 1