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 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/8/2016.An investigation is currently under way; 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: the grip came off upon opening the package.No patient involvement.

Manufacturer Narrative

(b)(4).A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was received for evaluation.A visual inspection was performed and the blue connector was found detached.The most likely root cause for the reported condition is lack of solvent.The solvent was dispensed inconsistently on the area where tube connects with the connector.This is due to an occluded solvent injection.The production personnel were notified of the reported issue.A quality alert was posted and functional stress tests will be conducted hourly by production.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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5416021
• MDR Text Key: 38290408
• Report Number: 9612030-2016-00065
• Device Sequence Number: 1
• Product Code: FEB
• 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: 02/02/2016

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: Other
• Device Model Number: 8888301614
• Device Catalogue Number: 8888301614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1