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

Model Number 775659

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien (b)(6) 2016 that a customer had an issue with an enteral feeding spike set.The customer states that the tubing itself set is spontaneously snapping.

Manufacturer Narrative

Submit date 10/11/2016.A device history record of the sample lot number was performed and confirmed that the product was produced accomplishing all quality requirements and was released according to all established procedures.One sample was received for evaluation.The received sample was evaluated visually and functionally; upon arrival the silicon tube was separated from the valve, this does not represent the way samples are released from the manufacturing site.The sample was used.During the investigation we unclogged the pvc lines and reconnected the silicon tube to the valve verifying that the product worked correctly.The silicon tubing and valve showed no signs of any damage or defect.We were unable to reproduce any detachment.The possible root cause could be: stretching peristaltic tubing before usage, incorrect placement in pump causing additional stress to the tubing and detachment, enfit female connector is not correctly adjusted to the transition connector and transition connector is not placed correctly to the g-tube or other tube that could go directly to the patient.No corrective actions will apply since the failure mode has not been confirmed to be any manufacturing issue with the sample received.This file will be considered verified because the sample was detached upon arrival; however, it will not be verified as a manufacturing defect.This complaint will be used for tracking and trending.

• 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 st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5802137
• MDR Text Key: 50465903
• Report Number: 1282497-2016-00497
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

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: Health Professional
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 161440039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1