MAUDE Adverse Event Report: COVIDIEN EPUMP INTL 1000ML FD AND FLUSH; PUMP, INFUSION, ENTERAL

Model Number	673662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
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 tubing disconnected automatically and leaked.There was no patient harm.
Additional Manufacturer Narrative
Investigation summary: the customer reported the tubing disconnected automatically and leaked.There was no patient injury/harm reported.The 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.As part of this review, the dimensions of the tubing and mistic connector were reviewed, and all were found to be in specification.Lot and failure mode trending was reviewed and no related trends were identified.One (1) sample was returned for evaluation.Visual inspection confirmed the report of tubing detachment/disconnection as the silicone tubing was detached from the mistic connector.Functional testing performed required reattaching the tubing to the mistic connector.The set was then connected to a pump and priming was completed without issue.Current process controls require one (1) of every eight (8) manufactured products be inspected with go no go fixture.Quality inspection results for the tensile test at the silicon tubing-mistic connector junction were reviewed and all the samples were found inside specification.A potential root cause of the confirmed detachment at the mistic connector is possible user misuse.The ifu states when loading the feed set to ¿grasp black ring retainer and gently stretch tubing around rotor and insert retainer into right pocket¿.Corrective actions are not necessary at this time as the historical manufacturing review determined the product met specification.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP INTL 1000ML FD AND FLUSH
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10936259
• Report Number: 1282497-2020-09750
• Device Sequence Number: 16289744
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 182220074
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 06/17/2021
• Patient Sequence Number: 1