MAUDE Adverse Event Report: REDO DOUBLE LUMEN TPN CATHETER SET

Model Number G07935

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.Initial reporter customer (person): (b)(6).Pma/510(k): not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a leak was discovered at the "top part" of the redo double lumen tpn catheter set in a (b)(6) year old patient.The catheter was inserted on (b)(6) 2021.This was the second event of leakage identified for the patient within two weeks.The first occurrence is referenced in the report with patient identifier: (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: a3, b5, d10, h6 - health eff clinical code grid and health eff impact code grid.Correction: b1, b2, h1.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information received on 19feb2021, it was reported that the catheter was placed in the right jugular vein for parenteral nutrition in which infusions of travasol and lipids were being administered.The device was secured to the patient with the specialized dressing tegaderm advance.There was no difficulty attaching or disconnecting ancillary devices such as extension with needleless connectors and delivery tubing to the catheter.Patient activity level was described as "quite restless." the device failed during hyperalimentation treatment.The first break occurred at home where the catheter was held in place with kite lock.The second break had a continuous infusion of solute.There was a need for relocation of another central line.The patient was hospitalized or required prolonged hospitalization.The device is not available to be returned.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.Hop.Sainte-justine, montreal, quebec, canada reported there was a leak at the top of the catheter.The patient was a two-year-old female whose activity level was reported to be ¿quite restless¿.The device was implanted in the patient¿s right jugular vein on (b)(6)2020 for administration of parenteral nutrition and was secured to the patient using a specialized dressing (tegaderm advance).No difficulty was reported when attaching or disconnecting ancillary devices (i.E.Extension tubing, needleless connectors).Travasol and lipids were infusing while the patient was at home when the leak was identified.It was reported that the device was held in place by the ¿kite lock¿.The device was removed and replaced with a redo double lumen tpn catheter set (rpn: c-tpns-5.0d-65-12-redo, lot number 9291884) on (b)(6) 2021 (report reference #: 1820334-2021-00286).On an unknown date, the new catheter began to leak at the top part of the catheter.The device was removed and replaced on an unknown date (report reference #: 1820334-2021-00287).A review of the documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history records (dhr) for lot 9291884 and the catheter component lot ni9291883 found no non-conformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with lot 9291884.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) provides the following information related to the reported failure mode: "warnings if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter." based on the information provided, no returned product, and the results of our investigation, a definitive cause of the failure could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• MDR Report Key: 11301124
• MDR Text Key: 266297110
• Report Number: 1820334-2021-00287
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079359
• UDI-Public: (01)00827002079359(17)211121(10)9291884
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: G07935
• Device Catalogue Number: C-TPNS-5.0D-65-12-REDO
• Device Lot Number: 9291884
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 2 YR