MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA KIT 11.5FX13.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813817009

Device Problems Partial Blockage (1065); Occlusion Within Device (1423); Sticking (1597)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/09/2016.An investigation is currently under way; 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 reports the venous line (blue color) of the catheter is blocked and the guide wire was stuck in the catheter and insertion was not possible.This was found during the insertion of the catheter in the patient and had to be replaced with a fresh catheter and again the 2nd fresh catheter was having same problem, the guide wire was stuck in the catheter, the venous line was blocked.

Manufacturer Narrative

Submit date: 02/09/2017.An investigation was performed.This complaint has not been confirmed.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.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 device history records (dhr) are reviewed for accuracy prior to product release.The complaint description states that [customer reports the needle does not allow the guide wire to pass through and insertion was not possible.This was found during the insertion of catheter into the patient and had to be replaced with a fresh catheter into the patient.].No sample or additional information was received for testing and investigation.If the sample is returned in the future, this complaint will be re-opened for further investigation.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary 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 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 2017-july-06.The manufacturing lot number associated with this complaint was reviewed and no failures related to the reported condition were identified.No nonconformance records (ncrs) for these issues in the reported lot number were found during device history record (dhr) review.No changes related to the reported condition were found within six months prior to lots manufacturing date.The product sample was returned to the manufacturing site for evaluation.The sample consisted of two duals catheters.The catheters were returned inside a generic plastic bag with no evidence of use.Visual inspection was performed and the catheters did not reveal visual issues.In order to confirm the reported condition, the guide wire returned with the catheter was passed through both extensions in both samples.In the first sample the guide wire passed easily through the arterial extension, however the guide wire did not pass through the hub in the venous lumen.For the second sample the guide wire did not pass through the hub in both lumens.The catheters were cut and it was observed that the hub was partially obstructed with a kind of resin inside the lumens.The process failure mode and effects analysis (pfmea) was reviewed for the failure mode.Additionally, an ishikawa diagram was used to determine the potential causes for this event.The reported condition has been confirmed.The evidence provided is enough to relate this event to the manufacturing operations.During sample evaluation the venous channel of the hub was found occluded due to an excess of dimethylacetamide used to bond the tube and hub.Based on previous analysis it can be concluded that the most possible root cause for the hub occlusion is related to manufacturing operations activities.The method in the procedure does not control the time the swab stick is submerged in the solvent and how much solvent is applied to the hub.It was decided to leverage this case to the corrective and preventative action (capa) for a complaint related to occlusion in the hub of a 11.5 dual lumen catheter.According to the sample analysis, it can be concluded that the identified root cause is the same in both complaints.The manufacturing date of the lot involved is before the implementation of the actions of this capa.Therefore the leverage to the mentioned capa is suitable.The actions of this capa include a modification of the procedure to include a better description of the necessary steps to perform a correct assembly of the hub-cannula union, performed an engineering study to determine the functionality of the d shape mandril on the product after solvent bonding application and implement the mandril with a d shape in the procedure per requirements.No further actions are required.No complaint triggers or trends were identified; therefore no further corrective or preventive actions were required.It must be noted that in-process controls as visual inspection and pressure testing according to procedure are in place to prevent nonconforming product from leaving the manufacturing operations.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

It was reported to covidien that a customer had an issue with a dialysis catheter.The customer reports the venous line (blue color) of the catheter is blocked and the guide wire was stuck in the catheter and insertion was not possible.This was found during the insertion of the catheter in the patient and had to be replaced with a fresh catheter and again the 2nd fresh catheter was having same problem, the guide wire was stuck in the catheter, the venous line was blocked.

• Brand Name: KIT 11.5FX13.5 CE MAHURKAR
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6090058
• MDR Text Key: 59968217
• Report Number: 3009211636-2016-00462
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1526500152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR