MAUDE Adverse Event Report: COVIDIEN J001FO 1000ML JOEY FEED BAG TYPE X30; PUMP, INFUSION, ENTERAL

Model Number J001FO

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.The customer reported a non-reportable product malfunction and returned the sample for evaluation.The sample arrived at the manufacturing site without the packaging or lot number.The sample was evaluated on july 15, 2020 by visual inspection and pumping tester.Upon evaluation a leakage occurred from the aff valve which is externally supplied.Cardinal health has requested that the supplier implement corrective actions to prevent the reoccurrence of the issue.The manufacturing site has also conducted containment action by 100% aff valve leak test at the occlusion/leak test machine under condition 1 bar, 20 seconds before sending the pumping section to the assembly line.This complaint will be used for qa tracking and trending purposes.

Event Description

The customer reported a non-reportable product malfunction and returned the sample for evaluation.Upon evaluation on july 15, 2020 a leakage occurred from the aff valve.

• Brand Name: J001FO 1000ML JOEY FEED BAG TYPE X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• Manufacturer (Section G): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10294821
• MDR Text Key: 199741761
• Report Number: 8040459-2020-00535
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: J001FO
• Device Catalogue Number: J001FO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1