MAUDE Adverse Event Report: COOK INC TWIN TURBO-FLO DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a twin turbo-flo double lumen peripherally inserted central venous catheter ruptured in the patient following a picc line insertion.The catheter was placed in the right basilic vein of the patient on (b)(6) 2022.On (b)(6) 2022, the picc line was removed and an approximately 0.8cm tear was discovered near the middle of the catheter (around 11cm from insertion site excluding the hub).The catheter was then flushed, and a leak was confirmed to be coming from the tear.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Occupation: senior purchasing agent.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 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
Investigation ¿ evaluation: (b)(6) hospital (hong kong) informed cook that on 17jul2022 catheter in a upicds-501-mpis-nt (twin turbo-flo double lumen peripherally inserted central venous catheter set) from lot 14223245x was broken.On (b)(6) 2022, the picc line was inserted into a patient.On (b)(6) 2022, the picc line was removed and found there was a tear in the catheter.It was reported that there were no adverse effects to the patient due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu), as well as a visual inspection and functional test of the returned device were conducted during the investigation.Cook received one used pic device.During tabletop testing it was noted that there was a rupture on the catheter at 16.5cm from the distal tip.Cook did not confirm that the device was manufactured out of 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 and the related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_upic_rev7] ¿turbo-flo peripherally inserted central venous catheters,¿ provides the following information to the user related to the reported failure mode: warnings: do not power inject contrast medium through catheter.Catheter rupture may result.Use of a 10 ml or larger syringe will reduce the risk of catheter rupture.Precautions: ¿if lumen flow is impeded, do not force injection or withdrawal of fluids.¿ product recommendations: 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.Heparin 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 lock.¿ instructions for use: catheter obturator preparation: ¿flush catheter with saline solution, heparinized saline solution or sterile water¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible the catheter experience too much pressure causing the rupture, though this cannot 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: TWIN TURBO-FLO DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• 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: 15135796
• Report Number: 1820334-2022-01296
• Device Sequence Number: 5268465
• Product Code: LJS
• UDI-Device Identifier: 00827002133099
• UDI-Public: (01)00827002133099(17)230920(10)14223245X
• Combination Product (Y/N): N
• PMA/510(K) Number: K161496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-501-MPIS-NT
• Device Lot Number: 14223245X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Patient Sex: Unknown