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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that when the feeding set was hung on the infusion rack, a large amount of nutrition liquid was found leaking from the pipeline.There was no adverse event with this reported issue.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported when the feeding set was hung on the infusion rack, a large amount of nutrition liquid was found leaking from the pipeline.There was no adverse event with this reported issue.The report refers to product code 673662, epump int.1000ml feed&flush ns, with lot number 181940211.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 and no related trends were identified.Five (5) samples were returned for evaluation.Visual inspection performed identified the mistic connector and silicon tubing were disconnected.Function testing performed after reconnection of the silicon tubing and mistic connector determined the devices functioned as intended without issue.A potential root cause of the confirmed silicon tubing and mistic connector detachment 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¿.Additional action will not be taken at this time.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: 11656010
• Report Number: 1282497-2021-10047
• Device Sequence Number: 14314995
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• Combination Product (Y/N): N
• 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): 08/02/2021

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: 181940211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1