MAUDE Adverse Event Report: COVIDIEN JOEY 500ML PUMP SET; ENTERAL FEEDING PUMP SET

Model Number 762055

Device Problem No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7/26/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump set.The customer reports that the formula would stop at the 2nd chamber and not flow through the tubing, so the mother would have to change up bags more frequently.

Manufacturer Narrative

Based on additional information received.Has been updated from "the customer reports that the formula would stop at the 2nd chamber and not flow through the tubing, so the mother would have to change up bags more frequently" to state "the customer reports that the formula would stop at the 2nd chamber and not flow through the tubing, so the mother would have to change up bags more frequently.The issue was noticed during the process of priming, there was no indication that the set was occluded".Based on the information received, the complaint has been updated and is not considered a reportable malfunction.

Event Description

The customer reports that the formula would stop at the 2nd chamber and not flow through the tubing, so the mother would have to change up bags more frequently.The issue was noticed during the process of priming, there was no indication that the set was occluded.

• Brand Name: JOEY 500ML PUMP SET
• Type of Device: ENTERAL FEEDING PUMP SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: matthew amaral ; 15 hampshire street; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5821907
• MDR Text Key: 51176644
• Report Number: 1282497-2016-00567
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 762055
• Device Catalogue Number: 762055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1