MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8813793009

Device Problems Detachment Of Device Component (1104); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary because no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of the photo was performed.The sample showed signs of use and revealed the arterial adapter (red) was disconnected from the tubing.According to the instructions for use (ifu), the customer must perform an inspection before using the device.The ifu also states to not infuse against a closed clamp or forcibly infuse a blocked catheter because backpressure could force the adapter out of the tubing.As part of the investigation process, the reported condition was analyzed, and an attempt was made to replicate it.Based on this replication of the reported condition and the instructions for use (ifu) it was confirmed that if the extension clamp was closed and a pressure was inserted, the backpressure would force the adapter out of the tubing.The reported condition has been confirmed.With the available information there is no enough evidence to relate this event with the manufacturing process.No triggers or trends were identified, and this is not a manufacturing related event, therefore, no corrective or preventive actions are required at this moment.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-procedure, during the patient position change the arterial luer adapter detached from the line and a small crack was found on the silicone tip of the extension tube.There was no harm to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7215128
• MDR Text Key: 98088227
• Report Number: 3009211636-2018-00027
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1