MAUDE Adverse Event Report: COVIDIEN PED-TBE 6FR:20" WGT W/ST. X10; FEEDING TUBE

Model Number 8884730741

Device Problems Detachment Of Device Component (1104); Obstruction of Flow (2423)

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

Event Date 10/21/2015

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 an issue with a feeding tube.The customer states that two days after they placed the feeding tube, obstruction was found.When the tube was removed, it was discovered that the weighted tip detached.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.Manufacturing records are routinely reviewed prior to the release of product to ensure process and product compliance.Because the sample was not provided by the customer, the sample evaluation could not be conducted and the issue reported by the customer could not be confirmed.Because the sample has not been received the failure mode could not be confirmed; therefore, the root cause was not identified for this incident.However, due to previous evaluations and samples reported with this failure mode the potential root cause that may cause this condition could be lack of solvent during the bonding process.Since this is a manual operation the reported condition could be originated due to a lack of solvent (thf) between the tip connector to bolus tip and hollow rod connector.The production personnel were notified about the reported condition.The acceptable quality limit level for sub assembly inspection was moved from normal to tighten and a quality alert was posted to reinforce the manual assembly and to alert the operators about the most critical sections that must be covered with enough solvent.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: PED-TBE 6FR:20" WGT W/ST. X10
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; covidien calle 9 sur no. 125 cuidad; / industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5466311
• MDR Text Key: 39545245
• Report Number: 9612030-2016-00091
• Device Sequence Number: 1
• Product Code: PIF
• 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
• Report Date: 02/04/2016

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: 8884730741
• Device Catalogue Number: 8884730741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• 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