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

Model Number 775659

Device Problems Air Leak (1008); Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/19/2016.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.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two used samples were received for evaluation.The sample was visually evaluated.Both samples were found to be clogged with dry formula along the pvc lines that obstructed the tube path at the valve level, no functional evaluation could be performed since the product could not be unclogged.A fault wasn¿t found to be related to manufacturing; possible root cause could be incorrect formula inside the tube or incorrect homogenization process for the formula but since the sample was received on inadequate conditions root cause could not be verified.No corrective actions will apply since failure mode was not confirmed related to manufacturing, it will be confirmed as unknown source.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: 6185286
• MDR Text Key: 63101736
• Report Number: 1282497-2016-01054
• 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,Followup,Followup
• Report Date: 10/04/2018

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1