MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; ENTERAL FEEDING PUMP SET

Model Number 775100

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; 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 when the spike set connection was made to the formula bottle the formula would drip out.There was no medical intervention or patient harm.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• 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: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6028551
• MDR Text Key: 57575040
• Report Number: 1282497-2016-00804
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 161410302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1