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

Model Number G03777

Device Problem Fitting Problem (2183)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Customer (person): (b)(6).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 turbo-ject single lumen power-injectable picc was leaking at "the base of the junction between [the] tubing and purple base".The device was implanted into the patient in (b)(6) 2020.On (b)(6) 2020, the products injected into the catheter were noticed to be leaking onto the patient's arm after a "noise of loss of vacuum (air leak) in the sampling tubes" was heard during a "serum rinse".Additional information has been requested regarding patient and event details but is not currently available.No adverse effects to the patient have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: b1, b2, h1 additional information: b5, h6 - patient code.H6 - patient code: no code available (3191) ¿ the device was replaced in an additional procedure.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

Additional information was received on 03dec2020.The leaking device was replaced in an additional procedure with a picc line of smaller diameter.It was reported that a smaller diameter device was used for the replacement because the medical team was unable to fit the same size picc "following a fibrosis".This proved to be an inconvenience for the rest of the patient's treatment.

Event Description

In additional information received on (b)(6)2021, it was reported that the line was placed to provide regular chemotherapy for the treatment of leukemia, when the leak was discovered, the patient was taken for blood tests.Nothing was in place on the patient except for the catheter.The device was secured to the patient with a statlock.The patient's activity level was reported to be inactive.Some of the medications that were infused through the line included chemotherapy, antibiotic therapy, hydration and parenteral nutrition.The failed hub was used frequently, as the patient was undergoing chemotherapy, with regular samples taken at least once a week for biological assessments.The device was flushed with a solvent used for chemotherapy, either g5% or nacl 0.9%.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.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.

Manufacturer Narrative

It was reported by (b)(6) from (b)(6), france that the device was leaking at the based of the junction between the tubing and the purple base.The complaint device was reported to be a turbo-ject single lumen power-injectable picc (rpn: upics-4.0-ct-nt-1110, lot number 13075978).The device as implanted in (b)(6) 2020 into the patient¿s arm.The indication for picc placement was treatment with regular chemotherapy for leukemia.The device as implanted in (b)(6) 2020 into the patient¿s arm and secured with a catheter fixation device (statlock, ref.: vppcspce).The device was used for chemotherapy, antibiotic therapy, hydration, and parenteral nutrition.The patient had regular samples drawn for biological assessment at least once per week.It was flushed with g5% or nacl 0.9%.On (b)(6) 2020 while sampling tubes were being obtained, there was an air leak noticed.The line was flushed and there was a visible leak in the device.It occurred at the junction of the hub and the catheter lumen.The device was removed and replace with another picc line (manufacturer unknown) with a smaller diameter as it was reported that the patient had fibrosis at the site.At the time of the failure, no ancillary devices were attached to the device.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One turbo-ject single lumen over-the-wire power-injectable picc was returned for evaluation.Upon a visual examination, it was noted that the clear tubing appeared to be pulled loose at the purple hub.A functional test confirmed the presence of a slow leak.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to assure device integrity.A review of the device history record (dhr) for lot 13075978 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that no other complaints were found for this lot.The evidence from the complaint file, device history record, complaint history and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house the instructions for use (ifu), provides the following information related to the reported failure mode: warnings: the safe and effective use of turbo-ject picc lines with power injector pressures set above 325 psi has not been established do not power inject if maximum injection rate cannon be verified to meet limit printed on catheter hub or extension tube.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter maintenance:.If clc-2000, microclave or other needless adapters approved for saline only lock are used, saline only catheter lock may be used.Catheter lock should be reestablished after every use or at least every 24 hours.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.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause for the failure could not be established.Cook was unable to rule out manufacturing, inadvertent stress placed on the device during care of the patient or patient activity, or maintenance of the device as a cause of the event.The appropriate personnel have been notified.Appropriate measures have been taken to address this issue, as a capa is currently in progress to investigate this failure mode.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: 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: 10949675
• MDR Text Key: 223774524
• Report Number: 1820334-2020-02244
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00827002037779
• UDI-Public: (01)00827002037779(17)220323(10)13075978
• Combination Product (y/n): N
• PMA/PMN Number: K132334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2022
• Device Model Number: G03777
• Device Catalogue Number: UPICS-4.0-CT-NT-1111
• Device Lot Number: 13075978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention