MAUDE Adverse Event Report: COVIDIEN ARGYLE CON TUBE N-C 6MMX3.1M STRL; CONNECTING TUBE

Model Number 8888301614

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 07/28/2016.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 connecting tube.The customer states that the blue connector was found detached prior to use on a patient.No patient involvement.

Manufacturer Narrative

The product was manufactured on 12/04/2015.The device history record (dhr) file was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.One unused sample without the original package or lot number was received or evaluation.After performing a visual inspection per procedure, the issue was found as the blue connector was detached from the pvc tubing.The root cause analysis as a result of the corrective and preventive action (capa) investigation, it was determined that the blue connector detachment could be generated by the design of the solvent supply being inadequate, the design of the assembly machine, or the process requiring continuous adjustments.Corrective action awareness training was performed to all personnel to ensure they are aware about this reported condition.The corrective and preventive actions are being documented through a formal capa.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: ARGYLE CON TUBE N-C 6MMX3.1M STRL
• Type of Device: CONNECTING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5830667
• MDR Text Key: 51894382
• Report Number: 9612030-2016-00335
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888301614
• Device Catalogue Number: 8888301614
• Device Lot Number: 532823264X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1