MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY 1000 ML FEED AND FLUSH SET; FEEDING BAG

Model Number 763662

Device Problems Fluid/Blood Leak (1250); Split (2537)

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

Event Date 11/08/2016

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) 2016 that an issue occurred with a feeding bag.The customer reports bags are splitting at the seams and leaking formula.Various patients involved, but not directly affected by the leaking bags.The date of events spanned several weeks and it was not possible for the customer to pin down the exact dates for all of these leakages.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two boxes were received on for evaluation, with a total of 47 new samples for evaluation.After the conclusion of a visual inspection and a functional testing, the failure mode reported was not confirmed; there was no leaking observed and the samples works as should.Corrective actions are not applicable.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO JOEY 1000 ML FEED AND FLUSH SET
• Type of Device: FEEDING BAG
• 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: edward almeida ; 15 hamsphire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6163403
• MDR Text Key: 62377968
• Report Number: 1282497-2016-01009
• Device Sequence Number: 1
• Product Code: KNT
• 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
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 763662
• Device Catalogue Number: 763662
• Device Lot Number: 161900259
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1