MAUDE Adverse Event Report: COVIDIEN 1000ML LRG BORE GRAVITY SET; PUMP, INFUSION, ENTERAL

Model Number 702505

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

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 states the bag has a tear in the left upper corner, just above the 1000 ml mark and leaked when the formula was put in.

Manufacturer Narrative

The device history record 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 outside of the original package.The sample was visually and functionally evaluated.During the functional evaluation a tear was detected on the bag causing the food to leak.Manufacturing personnel will be notified of the finding to prevent recurrence.This complaint will be closed with no further actions at this time and will be used for tracking and trending purposes.

• Brand Name: 1000ML LRG BORE GRAVITY SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8470220
• MDR Text Key: 140533978
• Report Number: 1282497-2019-08353
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 702505
• Device Catalogue Number: 702505
• Device Lot Number: 183270037
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2019
• Patient Sequence Number: 1