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

Model Number 8888128454P

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

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.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of this photo was performed and it revealed a cut in the extension tube of the catheter.Additionally, the catheter present sign of use (residues of blood).Manufacturing performs 100% visual inspection.A leakage/cracked would be detected during these processes.The reported condition has been confirmed with the photo provided by the customer.Based on picture provided by customer, 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.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.

Event Description

According to the reporter, the patient had a dialysis treatment via the catheter, and the nurse noted that there was only one hub suture in-situ, so an immobilizer device was applied.It was uncertain if there was an immobilizer used on the patient prior to this.The patient was presented to the renal unit with fresh blood under the catheter dressing.The nurse who attended the patient documented that the patient said they were carrying a bag of heavy groceries against their chest, at some point felt some degree of pain, but thought maybe they had just aggravated or pulled out the remaining suture.A nurse removed the catheter dressing for assessment of the bleeding, and a hole or slit was discovered on the arterial lumen of the catheter's extension.The nurse did note that there was no longer an immobilizer/stabilizer in place under the catheter, and the patient did admit to removing this device themselves.The patient denies using an instrument to remove the immobilizer device.There was no documentation indicating the patient reported on an approximate amount of blood lost between the lumen becoming compromised, and presentation to the renal unit with concerns about blood under the catheter dressing.They reported that the blood loss did not seemed significant, as the patient¿s hemoglobin was unchanged.There was also no documentation whether the clamps were moved to a new location after each treatment, however when nurses are taught central line/catheter care, moving the clamps is part of the procedure and they don¿t routinely document anything when it comes to moving lumen clamps.The catheter was inserted and has been in place for 1.5 years.It was also reported that the patient had fever a week ago and it's unclear if the central venous catheter (cvc) had anything to do with it.The catheter was promptly removed on the day the event happened and it was replaced with a new one.Post-catheter removal, the patient was monitored for an hour, with no apparent medical issues and received 2 doses of cipro 500 mg per os (po)/orally, and vanco 1.5 g iv prophylactically in 24 hours.The catheter tip was sent to the microbiology lab for testing, and 5 days later all results were negative.Blood cultures were also taken and these were also negative.The cleaning solution used routinely on the patient¿s catheter was aq swab, followed by a normal saline (ns) rinse to minimize skin irritation/reaction and the catheter site should be allowed to air dry completely after cleansing, drying time is 3 minutes as per guidelines given to the nurses.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the tube and connector were covered with dried blood.The tube past the connector had dried blood inside.A cut was revealed in the extension tube of the catheter.Pmv could not perform functional testing due the dried blood blocking the tube.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the cut in the tube of the catheter may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7555289
• MDR Text Key: 109908712
• Report Number: 3009211636-2018-00165
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521157842
• UDI-Public: 10884521157842
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 8888128454P
• Device Catalogue Number: 8888128454P
• Device Lot Number: 1521000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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