MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET

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	07/03/2021
Type of Reportable Event	Serious Injury
Additional 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.Customer (person): 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 that leakage occurred in a redo double lumen tpn catheter while flushing the catheter following an antibiotics infusion.The tunneled cvc was placed on (b)(6) 2021 and was secured to the patient with gauze and tegaderm.An infusion of antibiotics was administered on (b)(6) 2021, and around 2am, a leak occurred at the "y-connection site on the catheter" as 20ml of saline was flushed through.The nurse made a knot proximal to the leak and covered the site with tegaderm.The patient was then transported from malmo university hospital to lund university hospital for a picc line replacement the following day.Patient activity level was described as "active, not in bed." contrast media was not injected into the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.It was reported by (b)(6), sweden, that there was leakage in the catheter of a redo double lumen tpn catheter set (rpn: c-tpns-5.0d-65-12-redo, lot: 10275395).The female patient was being treated for ¿recurrent tumor disease¿.The device was placed on (b)(6) 2021 and was secured with gauze and an adhesive bandage (tegaderm).The patient¿s activity level was described as ¿active, not in bed¿.Contrast media was not injected into the catheter.On (b)(6) 2021, around 02:00, the catheter was flushed with saline.After the administration of antibiotics and during flushing of the catheter, the catheter began to leak at the ¿y-connection¿.It was reported that the nurses made a ¿knot proximally to the leakage site in order to stop the leakage and covered with tegaderm¿.The patient was then transferred from malmo university hospital to lund university hospital for a picc line replacement the following day.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used tpn catheter was returned to cook for evaluation.Leakage was confirmed at the distal end of the y-fitting in the connected tubing material.A visual inspection revealed the appearance of a split in the seam of the tubing.A knot in the tubing was also noted.Cook has concluded that the device was manufactured to specification.Additionally, 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 dhrs for the reported complaint device lot (10275395) and the related catheter component lot revealed no recorded non-conformances relevant to the reported failure mode.A database search identified one other event associated with the reported device lot for a leak that occurred on the same patient (reported under medwatch report #:1820334-2021-01932).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 from other customers have been received from the field, cook has concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The set lot was supplied with ifu c_t_tpn_rev7, which includes the following in relation to the 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 (b)(4) 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, inspection of the returned device, and the results of our investigation, a definitive root cause was unable to be established.Factors such as incorrect syringe size use or impeded flow leading to use of force can contribute to catheter rupture/leaking.However, neither can be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
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 #:1820334-2021-01932).This was reported in error, as the patient referenced in mfg.Report reference #:1820334-2021-01932 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
• 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: 12143352
• Report Number: 1820334-2021-01729
• Device Sequence Number: 17324380
• Product Code: FOZ
• UDI-Device Identifier: 00827002079359
• UDI-Public: (01)00827002079359(17)230217(10)10275395
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 01/27/2022
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 10/01/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female