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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: unknown.(b)(4).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 peripherally inserted central venous catheter was found to be leaking.The device was implanted on (b)(6) 2020 for infusion of chemotherapy.The device was fixed to the patient using a statlock.The patient was lying down while an infusion at 170ml / h of one liter of g5% + 2 grams of potassium chloride was in progress as well as an infusion of 40 mg of plitican when she noticed a leak in the line.As indicated in a photo provided, the product seems to be leaking at the purple winged hub.The leaking picc line was removed and new picc line was implanted the same day.The infusion of medication was completed without incident.Additional information regarding patient/event details has been requested but is not currently available.

Event Description

In additional information received on 01feb2021, it was reported that a needleless connector from another manufacturer was used.No instruments were used to tighten or release the hub.The catheter was maintained with physiological serum na.Ci 0.9%.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.D11: anti-reflux valve bbraun caresite luer access.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

B3 - date of event: the date of the event occurred on the night of (b)(6) 2021.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

In additional information received on 22jan2021, it was reported that the line was placed in the right arm of a bedridden patient.The leak was identified as occurring at the hub.A crack was not observed but nacl beaded when rinsing the catheter.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation it was reported by lucie bailly from c.H.R.U.De caen that there was a leakage issue with a turbo-ject single lumen peripherally inserted central venous catheter set (rpn: upics-3.0-ct-nt-1110, lot number 13203866).The patient was reported to be a bedridden female patient who was having the device placed for chemotherapy.The device was inserted into the patient's right arm on (b)(6) 2020.A bandage (statlock) and anti-reflux device were used with the device.The catheter was maintained with normal saline (nacl 0.9%).During the evening or early morning from (b)(6) 2021, the patient was lying down when they noticed a leak.When the leak was discovered, one liter of glucose 5% and 2 grams of potassium chloride was infusing at 170 ml/hour.It was reported that an infusion of 40 ml of plitican was also infusing at the same time.There was no crack reported to have been seen in the device, only ¿beading¿ when flushed.The device was removed and replaced.A review of the complaint history, device history record (dhr), and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One used turbo-ject® single lumen power-injectable picc was returned to cook for evaluation.Upon visual inspection, the clear tubing was noted to have partially separated from the purple hub where the leakage occurred.A functional test detected leakage.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 (13203866) and the related catheter component lots revealed no recorded non-conformances relevant to the reported failure mode.A database search did not identify any other events associated with the reported device lot.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 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 turbo-ject standard power injectable picc line was supplied with ifu t_ctpicc_rev6, which contains the following in relation to the reported failure mode: ¿warnings -the safe and effective use of turbo-ject picc lines with power injector pressure set above 325 psi 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.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.Catheter placement (fluoroscopic method) 14.Secure the catheter to the skin and dress in the standard fashion catheter placement (non- fluoroscopic method) 9.Secure the catheter to the skin and dress in the standard fashion¿ based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event was unable to be established.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 currently 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.

• Brand Name: TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• 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: 11186664
• MDR Text Key: 230691303
• Report Number: 1820334-2021-00106
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10827002558837
• UDI-Public: (01)10827002558837(17)220520(10)13203866
• Combination Product (y/n): N
• PMA/PMN Number: K111244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2021

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
• Device Operator: No Information
• Device Expiration Date: 05/20/2022
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-NT-1110
• Device Lot Number: 13203866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 01/22/2021; 01/22/2021; 05/11/2021
• Supplement Dates FDA Received: 01/28/2021; 02/08/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTI-REFLUX VALVE
• Patient Outcome(s): Required Intervention