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	10/09/2020
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.
Event or Problem Description
The customer reported there was wasted milk during priming process before feeding.Additional information provided by the customer on (b)(6) 2020 stated that the rn was priming the bag with the patient's milk and noticed leaking from the bottom pouch of the bag.They were unable to continue to prime and use the set.A new package was opened by the clinician to continue.
Additional Manufacturer Narrative
Investigation results: the customer reported there was wasted milk (leaking) observed during priming prior to feeding.No patient injury/harm was reported.A device history record review was unable to be performed as the reported lot number was unknown.During trend review, a trend was not identified for this failure mode.One (1) used sample was returned for evaluation.Visual inspection and functional testing performed confirmed the reported failure of leak between the bag and tubing.The root cause is determined to be manufacturing/process related.A corrective action was initiated to replace the rf sealing machine.No further action is required at this time.This device issue will continue to be monitored and trended.

• 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: 10853565
• Report Number: 1282497-2020-09632
• Device Sequence Number: 3490078
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/01/2021

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: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 04/01/2021
• Patient Sequence Number: 1