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

Model Number	672055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 the feeding set presented water filtration in the union of the bag with the device.There was no patient involvement therefor there was no patient injury, medical intervention, or adverse reaction associated with this event.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One used sample was received for evaluation.Visual and functional inspection was performed, and no failure was found.No formal investigation action is being taken since the reported issue could not be confirmed.This complaint will be used for tracking and trending purposes.

• Brand Name: KANG EPUMP 500ML PUMP SET-INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9402700
• Report Number: 1282497-2019-08799
• Device Sequence Number: 11304481
• Product Code: LZH
• UDI-Device Identifier: 10884521028142
• UDI-Public: 10884521028142
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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 Model Number: 672055
• Device Catalogue Number: 672055
• Device Lot Number: 192000052
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1