MAUDE Adverse Event Report: COVIDIEN JP 1000ML EPUMP SET; PUMP, INFUSION, ENTERAL

Model Number 973656

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

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 leaking occurred from the interface between the bag and tubing due to a crack.There was no harm to the patient.

Manufacturer Narrative

Investigation summary: the customer reported a leak was observed between the bag and tubing due to a crack.No patient injury/harm reported.A device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A trend review of the reported lot was completed with no trend identified.A historical complaint review for the reported failure mode was completed with no trend identified.One (1) sample was returned for evaluation.Visual inspection and functional testing performed confirmed the reported failure of leak.The root cause is determined to be manufacturing/production process related and a corrective action has been initiated to replace the rf sealing machine.No further action is required at this time.This device issue will continue to be monitored and trended.

• Brand Name: JP 1000ML EPUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11027714
• MDR Text Key: 222059256
• Report Number: 1282497-2020-09796
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 973656
• Device Catalogue Number: 973656
• Device Lot Number: 201320229
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1