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

Model Number 672055

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/22/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on 9/15/2016 that a customer had an issue with and enteral feeding pump set.The customer reports: the device did not allow the pass of nutrition.Additional information was requested on 9/16/2016, 9/20/2016 and 9/22/2016; however, to date there has been no response.

Manufacturer Narrative

Submit date: 12/05/2016.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were received for evaluation.Functional and visual evaluations were performed.The samples worked correctly and there was no issue found; there was no occlusion found in the sets.The reported issue could not be confirmed.Because the reported issue could not be confirmed, a root cause could not be determined.A corrective action is not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: KANG EPUMP 500ML PUMP SET-INTL
• Type of Device: ENTERAL FEEDING PUMP SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5971326
• MDR Text Key: 55714889
• Report Number: 1282497-2016-00718
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 672055
• Device Catalogue Number: 672055
• Device Lot Number: 151770045X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1