MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY EPUMP FEEDING BAG; FEEDING PUMP BAG

Device Problem Improper Device Output (2953)

Patient Problem Urinary Frequency (2275)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

This complaint has been sent to the vendor covidien several times beginning (b)(6) 2014 we are supplied with your kangaroo feeding bags for our daughter from our pharmacy.We notice that her feeding pump was way over her feeding amount which we assumed was a feeding pump issue.We use the measurements on the feeding bag which we were assuming was correct, however, we measured out by ml and filled the bag to 400 ml.This showed that the ml measurements were way off.We will be contacting our pharmacy, which is (b)(6) pharmacy in (b)(6) and also searching for other sources that we can have this type of error reported to the proper authorities.We noticed with our daughter she was blotted, and during cauterization we were getting excessive amount of urine.We believe this may have caused her stress.(b)(6).The attached complaint details have been forwarded on to our manufacturing plant for investigation.Upon completion of the investigation, these results will be shared with you.In a message dated (b)(6) 2014 09:59:01 a.M.Eastern daylight time, (b)(4) writes: good morning (b)(6), i apologize for any inconvenience this has caused.Per your email below, i will document the reported issue into our complaint tracking system.This complaint will be forwarded to our manufacturing plant, where they will conduct an investigation.In order for a thorough investigation to be conducted, i will need the following information: item number kangaroo epump anti-flow 1000ml.Lot number bar code number (01) 10884521022096.Is a sample available? the case was returned to our pharmacy, pharmacy also checked the same lot number and found these bags were not measuring correctly.It is a shame the end user needs to check the quality of the bags which is used to tube feed our daughter.Quantity/entire case or lot unknown what the amount our pharmacy has in stock.Is the patient diabetic: no.Was there any medical intervention required as a result: tbd.Was there any harm to the patient: tbd.Has an appointment at (b)(6).What type of formula is being used: promote with fiber.Did the pump alarm, if so, what was error displayed: no, the pump did not alarm her father and i know how long it takes for her feedings and just do not leave it to just wait for the alarm.Now i have a few questions; appears that these bags are labeled made in (b)(4), is this correct? does your facility check these products before they are distributed for the consumer's use? does the manufacturer in (b)(4) check the specifications or does covidien? email from customer (b)(6), has there been a correction made with the measurements of the feeding bags, i just need to know because obviously our pharmacy does not do an incoming inspection on the products they receive in.In a message dated (b)(6) 2014 12:13:43 p.M.Eastern daylight time, (b)(4) writes: good afternoon (b)(6), the attached complaint details have been forwarded on to our manufacturing plant for investigation.Upon completion of the investigation, those results will be shared with you.Thank you for bringing this concern to our attention.Kind regards, (b)(4).From: (b)(6) to: (b)(4).Subject: kangaroo feeding bags.We have not heard anything else from covidien, we still use a measuring beaker to make sure of the correct measurements.

• Brand Name: KANGAROO JOEY EPUMP FEEDING BAG
• Type of Device: FEEDING PUMP BAG
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 4080819
• MDR Text Key: 4744238
• Report Number: MW5038126
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/06/2014

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
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2014
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 46