MAUDE Adverse Event Report: COVIDIEN ARGYLE; TROCAR

Model Number 8888565036

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports the doctor noticed a leak after insertion and upon inspection, there was a hairline tear in the tubing.There was no harm to the patient.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿customer reports, the doctor noticed a leak after insertion and upon inspection, there was a hairline tear in the tubing.There was no harm to the patient.¿ a review of the device history record (dhr) for lot no.172090154 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7770160
• MDR Text Key: 116887041
• Report Number: 1282497-2018-00671
• Device Sequence Number: 1
• Product Code: DRC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888565036
• Device Catalogue Number: 8888565036
• Device Lot Number: 172090154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1