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

Model Number 60ENY

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2020

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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event 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.

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
• 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: 10130899
• MDR Text Key: 194402140
• Report Number: 9612030-2020-02490
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521212091
• UDI-Public: 10884521212091
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 60ENY
• Device Catalogue Number: 60ENY
• Device Lot Number: 1922519964
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2020
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Weight: 2