MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phone: (b)(6).Phone: (b)(6).Occupation: pediatrics.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a patient required a redo double lumen tpn catheter set for a cytostatics infusion.The catheter was placed in the right chest of the patient and secured with tegaderm.When the catheter was flushed with 0.9% saline to lock the catheter, the catheter started leaking at the distal end of the y-connection.The device was replaced with a new similar device.Patient activity was described as "active", visiting the hospital to receive treatment and being sent home upon completion.It was reported that power injection was not used.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported by (b)(6) of (b)(6), sweden that a redo double lumen tpn catheter set (rpn: c-tpns-5.0d-65-12-redo; lot: 10275395) leaked.The device was required by an unknown patient for cancer treatment.The catheter was placed in the patient¿s right chest on (b)(6) 2021 and secured with a clear adhesive dressing (¿thegaderm¿, rpn and lot unknown).The patient was sent home but would return to the hospital to receive treatment.On (b)(6) 2021, the patient reported to the hospital to receive a cytostatic infusion.After the infusion was complete, the user attempted to lock the catheter with a 0.9% saline flush.While flushing, the user noted that the catheter was leaking at the distal end of the y-connection.As a result, the patient required an additional procedure to remove and replace the device.No other adverse effects were reported.A review of the documentation including the complaint history, device history record, 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) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 10275395 and catheter component lot ni10275394 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there was one other complaint associated with this lot number for an additional event from the same customer with the same patient (mfg.Report reference #: 1820334-2021-01729).As 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 that 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: ¿ 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.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the failure could not be established.Based on the available information it was not possible to rule out patient activity, inadvertent excessive tension/force, catheter maintenance, user technique, inadvertent user error, or device failure as possible causes for this complaint event.The appropriate personnel have been notified.Per the 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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction - h10: it was reported in the investigation evaluation on the previous mdr submission that there was one other complaint associated lot number 10275395 for an additional event from the same customer with the same patient (mfg.Report reference #: 1820334-2021-01729).This was reported in error, as the patient referenced in mfg.Report reference #: 1820334-2021-01729 was a different patient from the same facility.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 or Problem 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
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12286877
• Report Number: 1820334-2021-01932
• Device Sequence Number: 4847791
• Product Code: FOZ
• UDI-Device Identifier: 00827002079359
• UDI-Public: (01)00827002079359(17)230217(10)10275395
• Combination Product (Y/N): N
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-5.0D-65-12-REDO
• Device Lot Number: 10275395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 01/27/2022
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 10/28/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown