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	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; 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 during priming, when the bag was filled with nutrition, they noted an external leakage at the connection tube.There was no patient involvement; therefore, no patient injury, medical intervention or adverse reactions were associated with this event.
Additional Manufacturer Narrative
Additional information h2, h3, h6 investigation conclusion the complaint stated during priming when the bag was filled with nutrition, they noted an external leakage at the connection tube.There were no other deficient products used during this event.There was no patient involvement.An investigation for product code 673662, epump int.1000ml feed&flush ns, with lot number 203280308 was performed.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.Lot and failure mode trending was reviewed, and no related adverse trends were identified.The reported product was not returned for evaluation, however, two (2) photographs were provided.Examination of the photographs confirmed the reported product failure of leak as a leak was identified at the bottom of the bag.A formal investigation was initiated to determine the root cause of the confirmed product failure.The root cause identified was related to the rf sealing machine used in the manufacturing process.A corrective action was initiated to replace the rf sealing machine and update associated manufacturing process documents.This complaint will be used for monitoring 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
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12058539
• Report Number: 1282497-2021-10320
• Device Sequence Number: 4359369
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: Health Professional
• Device Model Number: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 203280308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2021
• Supplement Date Received by Manufacturer: 06/20/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown