MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA PALINDROME EMERALD 28/45 KIT; DIALYSIS CATHETER

Model Number 8888145045C

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer states that the catheter was placed (b)(6) 2014.On (b)(6) 2014, the patient awoke in morning and noticed catheter was dislodged.No patient injury.Customer is unable to provide additional info.

Manufacturer Narrative

Submit date: 07/23/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Product sample was not returned and no photos were received.More information was requested to the customer and no additional information was provided for this analysis.There is a sample that has not been returned for investigation.When this sample arrives, this complaint will he reopened for further investigation.The manufacturing lot number associated with this complaint was 362321 the dhr review indicated that there was no quality issues associated with this defect mode.All the possible causes were identified.Dhr was reviewed and no deviations related to this failure mode were found.There are no non conformities related to the reported issue.This complaint has not been confirmed.The product sample was not returned to the manufacturing site for review.With the available information the most probable root cause can be related to misuse, however without the sample, this cannot be confirmed.No additional actions are 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 in place to prevent nonconforming product from leaving the manufacturing operations.Per procedure, manufacturing performs visual and dimensional inspection, in order to avoid a cuff issue in the catheter.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The product sample returned consisted of one assembled 14.5 fr heparin coated catheter.It presented all the components in her respective place.The cuff is securely attached with a bit of wear.All the possible causes were identified.The dhr was reviewed and no deviations related to this failure mode were found.There are not ncr related to the reported issue.As per the event description, the catheter was placed (b)(6) 2014.On (b)(6) 2014, the patient awoke in morning and noticed catheter was dislodged based on this, it can be noticed that the device functioned as intended during approximately 10 days, but more likely based on the investigation, the device was not placed properly on the patient, impairing the devices adherence during that time.This defect has not been confirmed.With the available information, the most probable root cause could be attributed to the employed insertion/placement method which affected the catheters adherence since after product sample evaluation, no defect could be confirmed.A preventive capa2 was opened before to address these issues.However after investigation, it was determined that it was not required and no actions were needed.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 nonconforming product from leaving the manufacturing operations.Per procedure, manufacturing performs 100% visual inspection during production, which would identify cuff defects in the catheter assembly.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Submit date: 10/29/2014.

• Brand Name: PALINDROME EMERALD 28/45 KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 4161732
• MDR Text Key: 15348732
• Report Number: 3009211636-2014-00020
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145045C
• Device Catalogue Number: 8888145045C
• Device Lot Number: 322716X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1