MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA PALINDR RT- P KIT 15 FR X 23CM; DIALYSIS CATHETER

Model Number 8888541023P

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/7/2017.An investigation is currently underway; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states that he observed an air entry in the track.It was caused by a leak on a par with the palindrome connector.

Manufacturer Narrative

Submit date: 03/02/2017.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, in process visual inspection and visual acceptance sampling) in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

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.One palindrome ¿ rt catheter and 2 unknown caps were received for evaluation.The catheter shows signs of use.Visual evaluation was performed and a crack was found on the arterial (red) and on the venous (blue) adapter.On the red and blue adapters the crack was on the thread pitch area.The adapters did not present marks that indicated the use of an instrument.An ishikawa diagram was used to determine the potential causes for the reported problem.The reported issue has been confirmed.The evidence provided is not enough to relate this event to the manufacturing operations.Based on the available information, it can be concluded that product was manufactured according to specifications and it functioned as intended for an undetermined amount of time; for this reason the adapters were more likely damaged during use and the most possible root cause can be considered as misuse.The instructions for use were not followed causing adapter over tightening.No complaint triggers or trends were identified and no harm was reported for this complaint, therefore, no further corrective or preventive actions are required at this moment.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that he observed an air entry in the track.It was caused by a leak on a par with the palindrome connector.The time of the procedure has been increased, the catheter has been changed.

• Brand Name: PALINDR RT- P KIT 15 FR X 23CM
• 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: 6306893
• MDR Text Key: 67109307
• Report Number: 3009211636-2017-00110
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888541023P
• Device Catalogue Number: 8888541023P
• Device Lot Number: 1525200109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1