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

Model Number 8888145016

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the device had a leak at the junction of extension tube and bifurcate, wherein patient had product inserted at approximately 0930h in medical imaging.Patient was for acute dialysis in the renal unit at approximately 1600h.Treatment was commenced at approximately 1630h.At 1800h the dialysis machine alarmed with a "microbubble detected" message.Nurse attended machine alarm and noticed the catheter dressing was saturated with blood.Blood was also visible on the patient clothing.Bloodlines was disconnected and nurses aspirated the arterial lumen of the catheter and heard a "sucking" sound.The arterial silicone extension was then clamped with a metal clamp.Nurse then contacted the vascular access nurse who requested the catheter body be clamped.Within 1 hour, the catheter was then removed.Nurse stated that the small original hole was on the lateral side of the arterial extension near the bifurcation.The evident tear seen was due to the metal clamps, not the original leak.Patient had an existing non-cuffed femoral catheter that had not been removed.In order to resolve the issue, treatment was recommenced via this non-cuffed femoral catheter.There was no patient injury.

Manufacturer Narrative

Evaluation summary: because no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs 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 (possibly residues of blood and a hair).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.The extension venous did not present any defect related with reported condition.Manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.No trends 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 purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 st.; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7370060
• MDR Text Key: 103550183
• Report Number: 3009211636-2018-00090
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 62