MAUDE Adverse Event Report: COVIDIEN EXT SET BIFURCATED 60 ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	60ENY
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2020
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 that the nurse could not flush anything through the tubing.The patient did not suffer any injury.The extension tubing was replaced.The ng tube did not need replacement.
Additional Manufacturer Narrative
H 3 evaluation summary the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections, per established sampling levels were within acceptable limits during the production process.One used sample was received at the manufacturing plant for evaluation.Visual and functional inspection was performed, and the reported condition was confirmed.The returned device does not meet specifications.The most likely root cause of this condition could be a workmanship issue.The manufacturing process was reviewed and during the assembly, excess solvent used during the bonding process could be generated by the dispenser when the application is performed without the guide pin.No action plan is deemed required at this time because the reported condition is below the approved acceptable quality limit.However, as a precautionary measure, this process will be changed to red to heighten awareness of the issue and to detect possible issues.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: EXT SET BIFURCATED 60 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: 10130899
• Report Number: 9612030-2020-02490
• Device Sequence Number: 2042847
• Product Code: PIF
• UDI-Device Identifier: 10884521212091
• UDI-Public: 10884521212091
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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: 60ENY
• Device Catalogue Number: 60ENY
• Device Lot Number: 1922519964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Weight: 2