MAUDE Adverse Event Report: COVIDIEN TROCAR CATH 24FR

Model Number 8888561050

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

Event Description

The customer states at the bottom of the product the hole was not punched; the little plastic knot had to be removed manually.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards. because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time. functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: TROCAR CATH 24FR
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7975041
• MDR Text Key: 124330931
• Report Number: 9611018-2018-00303
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/17/2019

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: 8888561050
• Device Catalogue Number: 8888561050
• Device Lot Number: 17J086FHX
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1