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

Model Number	G34548
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name: turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.Initial reporter occupation: ir lead tech.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 both hubs of a turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc separated from their corresponding extension tubing.The patient was in the user facility's critical care unit (ccu).The orange hub was heparin locked, while the white hub was used for infusion of "milrinone,ns".As a result of the separations, the device was removed.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Interventional radiology lead technician.Initial report should also be considered a 15 day report.Health effect clinical code and health effect impact code.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
Additional information provided on 29jun2021 stated the failure was noted 6 days after placement.The device was secured with sutures and an adhesive bandage.The device was being used for bedside infusions, but power injection was not used.The patient required a peripherally inserted central venous catheter (picc) line exchange with general anesthesia following disconnection.
Event or Problem Description
Additional information was provided on 15oct2021 indicating that there were no additional adverse effects experience by the patient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation on (b)(6) 2021, cook medical inc.Received a complaint from (b)(6) hospital indicating that difficulty was experienced with the supplied catheter (rpn: stumd4.0-nt-60-w-ns-0-pic-abrm) from the turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc (rpn: upicds-4.0-ct-nt-abrm-1111, lot 13755487).It was reported that the white and orange hubs separated from the extension tubing.The device was being used for bedside infusions.Power injection was not used.The patient required a picc line exchange under general anesthesia following disconnection.No additional harm to the patient has been reported.Reviews of the documentation including the complaint history, device history record, instructions of use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for lot 13755487, component lot ic13628826 and supplied lot 2097135.1, found no nonconformances that could have contributed to the reported failure mode.It should be noted that five other complaints have been associated with the final product lot number.All complaints were from the same facility, with three reporting an identical failure mode.Cook also reviewed product labeling.Instructions for use (ifu) document t_upicabrmtt_rev1 [cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducers] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: intended use the cook spectrum turbo-ject peripherally inserted central venous catheter (picc) sets are indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in ct studies¿ the maximum pressure limit setting for power injectors used with the spectrum turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated, as shown on the following table.Warnings ¿ the safe and effective use of spectrum turbo-ject picc lines with power injector pressures 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.¿ to safely use catheters with a power injector, the technician/health care professional must verify: ¿ prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.How supplied upon removal from package, inspect the product to ensure no damage has occurred.The information provided upon review of the dmr, ifu, dhr, dhf, and returned device suggests that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the failure could not be established.It was determined in a previous capa investigation that the product issue could be related to the inadequate flexural strength in a previous hub design change.The appropriate personnel have been notified.Per the risk assessment no further action is required.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: COOK SPECTRUM TURBO-JECT
• 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: 12094875
• Report Number: 1820334-2021-01654
• Device Sequence Number: 3832457
• Product Code: LJS
• UDI-Device Identifier: 00827002345485
• UDI-Public: (01)00827002345485(17)221228(10)13755487
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2022

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: 12/28/2022
• Device Model Number: G34548
• Device Catalogue Number: UPICDS-4.0-CT-NT-ABRM-1111
• Device Lot Number: 13755487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 10/15/2021; 03/11/2022
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/22/2021; 10/22/2021; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADHESIVE BANDAGE (TEGADERM)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 MO
• Patient Sex: Male