MAUDE Adverse Event Report: COVIDIEN J011RO JOEY ADAPUTER TYPE X30; PUMP, INFUSION, ENTERAL

Model Number J011RO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

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 reports that the fluid leaked from the aff valve connector.

Manufacturer Narrative

The device history record review of the reported lot number was not reviewed because of the lot number was not provided.However, all record from manufacturing lots were reviewed to ensure that products were released meeting all quality release specifications at the time of manufacture.One sample was received and evaluated.The reported condition was confirmed.The investigation found that there was an aff valve leakage due to an incomplete assembly of the aff valve.The manufacturing facility determined that the root cause was from the lapse of maintenance of certain manufacturing equipment.The root cause is related to non-periodic inspection of the detection sensor on the equipment.Corrective/preventive actions taken is that a full review of the current status of pistons and sensors will be assessed, and maintenance orders have been initiated.

• Brand Name: J011RO JOEY ADAPUTER TYPE X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• MDR Report Key: 9405666
• MDR Text Key: 169088798
• Report Number: 8040459-2019-00507
• Device Sequence Number: 1
• Product Code: LZH
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: J011RO
• Device Catalogue Number: J011RO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2019
• Patient Sequence Number: 1