MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 8888577775

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the drain snapped and the patient was injured.

Manufacturer Narrative

Submit date: 1/24/2018.An investigation was performed.Since lot number was invalid, a manufacturing device history review or product/process changes review for the involved lot number could not be performed.However, all device history records (dhrs) are reviewed for accuracy prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No trends or triggers have been found for this particularly event, therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for (b)(6), 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6498221
• MDR Text Key: 72951179
• Report Number: 3009211636-2017-05083
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888577775
• Device Catalogue Number: 8888577775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: 03/27/2017
• Supplement Dates FDA Received: 01/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other