MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNKNOWN

Device Problem Defective Device (2588)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Submit date: 9/26/2016.An investigation is currently under way; upon completion the results will be forwarded.Additional information has been requested on (b)(6) 2016 with no response.If additional pertinent information is provided, a follow up will be sent.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer reported a defective dialysis catheter that was removed from the patient due to an infection.

Manufacturer Narrative

Additional information was received on 09/27/2016.The customer reported the catheter was cracked above the y.The customer stated she believes it was removed because of the crack, not because of the infection.There is no further information.There is no wrapping, sample, or anything to identify the product the issue occurred with.

Manufacturer Narrative

The actual sample involved in the reported incident was not returned for evaluation.There was no additional information, pictures or videos 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 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 available information was analyzed and it did not allow a confirming root cause for the event.More information was requested to the customer and no additional evidence was provided for this analysis.This complaint will be reopened and updated accordingly if the product sample is returned or if additional information becomes available.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.

• Brand Name: DIALYSIS UNKNOWN
• 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: 5976632
• MDR Text Key: 55609672
• Report Number: 3009211636-2016-00411
• Device Sequence Number: 1
• Product Code: MSD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other