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 06/03/2020

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 feeding through extension tubing.There was no patient harm reported.The extension tubing was replaced.The nasogastric (ng) tube did not require a replacement.

Manufacturer Narrative

A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation one decontaminated sample was received for evaluation.The reported condition is confirmed.The most likely root cause for this condition could be a result of a workmanship issue.The manufacturing process was reviewed and during the assembly process it is possible for excess solvent to be applied to the device during the bonding process generated by dispenser when the application is performed without a guide pin.The reported condition was evaluated against the acceptable quality limit (aql) and no action plan is required since the complaint report represents an occurrence rate of 0.003% which is below the approved aql of 0.65 %.The current process is running according to product specifications meeting quality acceptance criteria.We 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: 10165644
• MDR Text Key: 195604065
• Report Number: 9612030-2020-02500
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 534285664X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2020
• Patient Sequence Number: 1
• Patient Age: 20 DA
• Patient Weight: 1