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

Model Number 762055

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with an enteral feeding pump set.The customer reports the bags are leaking and there are holes in the bags.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: JOEY 500ML PUMP SET
• Type of Device: ENTERAL FEEDING PUMP SET
• Manufacturer (Section D): COVDIIEN; 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6307446
• MDR Text Key: 67110350
• Report Number: 1282497-2017-00204
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 762055
• Device Catalogue Number: 762055
• Device Lot Number: 163350020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1