MAUDE Adverse Event Report: COVIDIEN MP SAFETY SCREW SPIKE SET; ENTERAL FEEDING SPIKE SET

Model Number 775659

Device Problems Air Leak (1008); Break (1069); Fluid/Blood Leak (1250); Connection Problem (2900)

Event Date 11/19/2016

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 a customer had an issue with an enteral feeding spike set.The customer states that there was a lack of connection between the set and the connection of the diet.The set was breaking easily and the diet was leaking from the side.Air bubbles entered into the set.There was no injury reported.

• Brand Name: MP SAFETY SCREW SPIKE SET
• Type of Device: ENTERAL FEEDING SPIKE 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 street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6185339
• MDR Text Key: 241268362
• Report Number: 1282497-2016-01056
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 160150042X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1