MAUDE Adverse Event Report: COOK INC TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Customer (person): mobile phone: (b)(6).Line 2 (of address): (b)(6).Occupation: manager.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 a (b)(6)-year-old female patient had a turbo-ject® single lumen power-injectable picc placed under ultrasound guidance in the middle left upper arm.The patient's activity level was described as "normal".The device was being used for infusion of irritating drugs such as chemotherapy drugs and hyperdialysis with a "longer infusion period".The device was secured to the patient using 10x12 cm waterproof, transparent paste with the catheter fixed in a "u" shape.During hospitalization, at the end of each infusion, the physician used a catheter irrigator prefilled with saline for pulse flushing and positive pressure sealing of the catheter at a qualified maintenance hospital.Saline was used roughly one to two times a week for maintenance.Two months after placement and during drug infusion, the picc extension tubing "ruptured" and leaked.The catheter was removed and replaced with a similar device.No other adverse effects were reported.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6), a representative for henan yijianyuan trading co.Ltd., china reported that the extension tube on a cook picc was ruptured and leaking.The complaint device was reported to be a turbo-ject® single lumen power-injectable picc (rpn: (b)(4), lot number 10339819).The patient was a 61 year-old female who weighed 66 kilograms.She had been diagnosed with burkitt lymphoma.She was reported to have had a normal activity level.Her peripheral venous condition was reported to have not been good.The device was place on (b)(6) 2020 into the middle left upper arm of the patient using ultrasound guidance.The hub of the catheter was connected to a needleless connector (claver¿s single cavity connector (b)(6)).The device was secured to the patient using a waterproof and transparent bandage (size 10-12 mm).The catheter was fixed in a ¿u¿ shape.No difficulty was reported attached or disconnecting the catheter to ancillary devices.While the patient was hospitalized, at the end of each infusion, the doctor used a prefill catheter irrigator that contained normal saline for pulse flushing and positive pressure sealing of the catheter.After discharge but during the interval of treatment the patient went to a qualified hospital for maintenance of the device.Saline was used once or twice a week for the maintenance.During an infusion of medication it was noted that the extension tube was ruptured and leaking.The catheter was withdrawn immediately and replaced with a peripheral intravenous cannula.The infusion of irritating drugs (chemotherapy drugs, hyperdialysis, etc.) had to be completed over a longer infusion period as the patient¿ venous condition was reported to be ¿not good.¿ no other adverse effects to the patient have been reported.A photo of the device was provided by the customer when the complaint was reported.The rupture was not able to be identified in the photo.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.Upon visual inspection, a separation was identified at the junction of the purple hub and the clear extension tubing, resulting in leaking.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot 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 ifu supplied with the device states the following in consideration of the reported failure mode: -the safe and effective use of turbo-ject picc lines with power injector pressures set above 325psi has not been established -do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.-to safely use turbo-ject picc lines with a power injector, the technician/health care profession must verify: the catheter lumen has "ct" on the hub to indicate the lumen is power injectable -prior to use that the maximum pressure limit is set at or below 325psi and that the maximum flow rate is at or below that which is list on the catheter.Dynamic and static pressure test results are shown in the following table (provided in the ifu) precautions ¿ if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.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 a catheter locking solution.Note: if clc-2000, microclave or other needless adapters approved for saline only lock are used, saline only catheter lock may be used.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 twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should be again be flushed with twice the indicated lumen volume using normal saline before reestablishing catheter lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event could not be established.It was reported that the patient was active.It was not possible to rule care and maintenance of the device, or inadvertent tension placed on the device as a cause of the event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures have been initiated to address this failure mode.A capa is in progress to further investigate this failure mode with this device.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: h6- annexes b, c, and d.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 Description

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

• Brand Name: TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC
• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11663816
• MDR Text Key: 245334928
• Report Number: 1820334-2021-01130
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10827002345192
• UDI-Public: (01)10827002345192(17)220219(10)10339819
• Combination Product (y/n): N
• PMA/PMN Number: K132334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-NT-1111
• Device Lot Number: 10339819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLAVER¿S¿SINGLE-CAVITY CONNECTOR MC100; CLAVER¿S¿SINGLE-CAVITY CONNECTOR MC100
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 66