MAUDE Adverse Event Report: COVIDIEIN PALINDROME - P 23/40 VT KIT; DIALYSIS CATHETER

Model Number 8888145040P

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Thrombus (2101)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 07/18/2016.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 needle was punctured to the skin.The guide wire would not forward inside the puncture needle.The guide wire could not be removed through the puncture needle so they were removed from the patient together and another device was used.There was a blood clot between the puncture needle and guide wire.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The product sample was received at the site for analysis and investigation; it consisted of two incomplete kits of the product palindrome which came inside a generic plastic bag.Visual inspection was performed and the components did not show signs of use.As part of the evaluation, the guide wires were passed through the introducer needle and resulted in the guide wire passing easily through the introducer needle.Dimensional testing was performed for the guide wires and the introducer needle and the measurements were within specification.This component has defined characteristics as part of its design which makes it flexible for gentle manipulation during use.The sample evaluation and dimensional tests revealed that no defective conditions were identified in the guide wires or needle.There is no evidence to link this failure with manufacturing activities.Based on the available information the needle could be blocked by a biological particle during the needle insertion and the most possible cause for this issue is related to an inappropriate manipulation by the user.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.This complaint will be recorded for tracking and trending purposes.

• Brand Name: PALINDROME - P 23/40 VT KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEIN; 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: 5802042
• MDR Text Key: 49784725
• Report Number: 3009211636-2016-00318
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145040P
• Device Catalogue Number: 8888145040P
• Device Lot Number: 1526600183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1