MAUDE Adverse Event Report: COVIDIEN 1000ML LRG BORE GRAVITY SET; GRAVITY FEEDING SET

Model Number 702505

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 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 a issue with a gravity feeding set.The customer reported that the tubing was becoming unattached from the purple connector resulting in leakage.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A possible root cause can be related to the drying process at the manufacturing site.The time to dry the adhesive between the tubing and female connector was not done properly to attach the connector to the tubing.The manufacturing process was updated to assure the adhesive is properly applied to the tubing and that the drying process is correct.This complaint will be used for tracking and trending purposes.

• Brand Name: 1000ML LRG BORE GRAVITY SET
• Type of Device: GRAVITY FEEDING 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5570657
• MDR Text Key: 43036793
• Report Number: 1282497-2016-00116
• Device Sequence Number: 1
• Product Code: FPD
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 702505
• Device Catalogue Number: 702505
• Device Lot Number: 160220070X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1