MAUDE Adverse Event Report: COVIDIEN EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	772055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
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 at approximately 0205 in the morning, the nurse went to pour a feed into the 500ml bag.The nurse thought she missed as the formula leaked all over.The nurse looked and noticed that the bag itself was leaking from the distal end of the bag, yet the proximal head of the tubing.About 50ml of formula was lost/wasted.No patient injury.

• Brand Name: EPUMP 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10468667
• Report Number: 1282497-2020-09389
• Device Sequence Number: 19583542
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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 Expiration Date: 05/31/2023
• Device Model Number: 772055
• Device Catalogue Number: 772055
• Device Lot Number: 201600065
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/28/2020
• Patient Sequence Number: 1