MAUDE Adverse Event Report: COVIDIEN PERMCATH 40CM; DIALYSIS CATHETER

Model Number 8817749001

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 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 physician found that the device was leaking after flushing it.A hole was found on the body of the device.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The device history record (dhr) review indicated that there was no quality issues associated with this failure.All dhrs are reviewed for accuracy prior to product release.Since the sample was not returned, there is not enough evidence to determine what could cause this event.Should the sample be returned in the future, this complaint will be re-opened for further investigation.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.As per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Submit date 07/12/2016 the investigation was updated due to the receipt of a sample from the customer.Sample consisted of one permcath catheter which presented signs of use.Visual inspection was performed and it was observed that the catheter did not present any defects.In order to confirm the reported condition a functional test was performed and as a result a leak was identified from a cut on the shaft of the catheter.The cut looks irregular.An ishikawa diagram was used to determine the potential causes for this event.Manufacturing performs 100% visual inspection per procedure and 100% leak testing.Through visual evaluation it was noted there was one cut in the catheter¿s shaft.Due to the appearance of the catheter received it is possible that the catheter body was damaged by instruments with sharp or rough edges during clinical use.Clinician pinches catheter during hub changes or other normal use causing a concentrated stress point, resulting in a catheter leakage or breakage.As per the instructions for use, the customer has to perform a visual inspection before using the device.All device history records (dhrs) are reviewed for accuracy prior to product release.The defect occurred after being in use in a patient.The reported condition has been confirmed.The product sample was returned to the manufacturing site for review and based on the available information, it can be concluded that product was manufactured according to specifications; therefore the most probable root cause can be considered as misuse.This issue was more likely damaged during use caused due to an inappropriate manipulation by the user.

• Brand Name: PERMCATH 40CM
• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5351720
• MDR Text Key: 35381273
• Report Number: 3009211636-2016-00023
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817749001
• Device Catalogue Number: 8817749001
• Device Lot Number: 215904X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2016; 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1