MAUDE Adverse Event Report: COVIDIEN MAHURKAR 11.5FR 24CM; DIALYSIS CATHETER

Model Number 8831661001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 06/23/2016.An investigation is currently underway; 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 dialysis catheter.The customer states the device was used for continuous dialysis.There was blood loss from the brown luer lock adapter.The operator was exposed to blood and for this reason she received the prophylaxis for biohazard.No patient harm reported.

Manufacturer Narrative

The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.As no lot number was identified, a manufacturing device history record (dhr) review or product/process change review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event, however, the following potential causes were identified: inattention, misuse, error in catheter placement, excessive force when inserting the catheter, incoming inspection not performed, or defective material.This event is addressed through a corrective and preventative action (capa) and a health hazard evaluation (hhe).No additional actions were required.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 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.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Submit date: 02/09/2017.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 revealed that the blue adapter was not returned with the catheter.The red adapter did not present any issues.As per the instructions for use, it necessary that the customer perform an inspection before using the device.Do not use the catheter if it is damaged or appears defective.Over tightening catheter connections can crack some adapters.A possible root cause can be due to over tightening the adapter.A corrective action is not applicable at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: MAHURKAR 11.5FR 24CM
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5745136
• MDR Text Key: 48038253
• Report Number: 3009211636-2016-00272
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8831661001
• Device Catalogue Number: 8831661001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other