MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145015

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states during a dialysis session air bubbles were discovered in the bloodline.Treatment was continued at a decreased blood flow.Three days later a small leak was discovered on the arterial extension tube near the clamp area.Surgical tape was placed on the hole and the dialysis treatment was completed.The catheter was replaced with a new device the next day.There was no patie nt injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: a device history 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.All dhr are reviewed for accuracy prior to product release.Sample consisted in one catheter used came inside a generic plastic bag.Visual evaluation of the sample reveals signs of use (residues of blood).Visual inspection was performed and it was observed that the arterial extension has a hole/cut and present marks that indicate the use of some instrument.Manufacturing performs 100% visual inspection, 100% leak test and qa in process inspection.The reported condition has been confirmed.The physical sample involved in the reported incident was returned for evaluation.Based on the testing evaluation, it can be concluded that the device functioned as intended for an undetermined amount of time.100% devices are inspected for leaks or cuts in the extensions.The most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to the use of strong cleaning agents, sharp object, excessive force during of use and repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.No tre nds or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending p urposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7232426
• MDR Text Key: 98748708
• Report Number: 3009211636-2018-00033
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K111372
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 306621X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1