MAUDE Adverse Event Report: COVIDIEN EPUMP RE-CERTIFICATION SET; PUMP, INFUSION, ENTERAL

Model Number	776150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the recertification sets are leaking and causing all recertifications to fail.Additional information received stated that the leak was around the plastic tab on the set, almost like a push point on the set.This occurred during testing.No patient involvement.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported the recertification sets are leaking and causing failure.Additional information stated the leak occurred around the plastic tab on the set (almost like a push point on the set).This occurred during testing.No patient involvement.This report refers to product code 776150, epump burette re-certification, with lot number 200060032, manufactured on 16-jan-2020.A device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Lot and failure mode trending was reviewed an no related trends were identified.Two (2) samples were received for evaluation.Visual and function inspection performed found no failure.The returned devices functioned per specification and the report of leak was no confirmed.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP RE-CERTIFICATION SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11817038
• Report Number: 1282497-2021-10187
• Device Sequence Number: 14240106
• Product Code: LZH
• UDI-Device Identifier: 10884521022126
• UDI-Public: 10884521022126
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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
• Operator of Device: No Information
• Device Model Number: 776150
• Device Catalogue Number: 776150
• Device Lot Number: 200060032
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/01/2021
• Supplement Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1