MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML FEED/FLUSH SET; PUMP, INFUSION, ENTERAL

Model Number 763662

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

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 reported that the feeding bag had many slits and there were leaks near the tubing.The feed flowed freely out of the bag and onto the floor.

Manufacturer Narrative

The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One used sample was received for evaluation.A visual inspection was performed, and it was detected that the bag has a cut near the tubing connection.The condition was not determined as a manufacturing issue since after the production line assessment no potential root causes were detected and there is no trend for a damaged bag related to this part number.It is possible that the condition occurred post manufacturing during use.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: JOEY 1000ML FEED/FLUSH SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9161546
• MDR Text Key: 164430302
• Report Number: 1282497-2019-08703
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072312
• UDI-Public: 10884521072312
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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
• Device Operator: No Information
• Device Model Number: 763662
• Device Catalogue Number: 763662
• Device Lot Number: 183340175
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 01/27/2020
• Patient Sequence Number: 1