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	06/03/2020
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 feeding through extension tubing.There was no patient harm reported.The extension tubing was replaced.The nasogastric (ng) tube did not require a replacement.
Additional 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
• 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: 10165644
• Report Number: 9612030-2020-02500
• Device Sequence Number: 3083601
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 534285664X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1
• Patient Age: 20 DA
• Patient Weight: 1