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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Fitting Problem (2183)

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

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Device name: turbo-ject¿ double lumen minocycline/rifampin over-the-wire power-injectable picc.Concomitant products: grip lok- universal securement device- tidi products, ref# (b)(4), sutures- covidien dermalon monofilament nylon 3.0 ref# (b)(4), tegaderm- cardinal health transparent dressing 4 x 4.75, ref# (b)(4).Initial health 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 Description

It was reported a turbo-ject¿ single lumen minocycline/rifampin power-injectable picc broke 55 days after initial placement.The patient was receiving an mivf infusion.When flushing the medication, a crack was noticed on the picc line.The next day the device was removed and replaced with a similar device.Power injection was not used.The device was secured to the patient with sutures, an adhesive bandage and k-loc.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Correction: h6 - annex a.Investigation ¿ evaluation.Lurie children¿s hospital (united states) informed cook on 16aug2021 of a hub issue for a cook spectrum turbo-ject power-injectable picc (rpn: upicds-4.0-ct-nt-abrm-1111, lot 13678806).The hub was slightly separated from the tubing and the picc line was removed.The picc line was in the patient for 47 days before failure was noticed.The patient required another procedure to remove and replace the broken line.No other adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, device history record, quality control, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record 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 (13678806) revealed no recorded non-conformances relevant to the failure mode.A database search for complaint on the reported lot found six additional complaints reported from the field.All of the additional complaints are from the same user facility for the same reported failure.While there are additional complaints on this lot, there is currently no evidence of manufacturing deficiency.The product ifu, [t_upicabrmtt_rev1] ¿cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducers,¿ provides the following information to the user related to the reported failure mode: intended use: ¿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 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 turbo-ject picc lines with a power injector, the technician/health care professional 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 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.Dynamic and statis pressure test results are shown in the following table.[4fr single hub has a 0.76 ml priming volume, 5ml/sec labeled flow rate, 177 psi maximum flow, 226 psi 37 degrees celsius average static burst water pressure, 217-233 psi 37 degrees celsius range static burst pressure.] *maximum flow rate pressures are determined with pump safety cut-off set at 325 psi, using contrast media with a viscosity of 11.8 cp.**static burst pressure is the failure point of the catheter when totally occluded.Warning: power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.¿ precautions if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Patient movement can case catheter tip displacement.Catheters places via an antecubital vein have shown tip movement of up to 10 cm with motion of the extremity.Catheter size should be as small as the use will allow.Instructions for use power injection procedure ¿3.Remove any injection/needless caps from the spectrum turbo-ject picc.4.Attach a 10ml (or larger) syringe filled with sterile normal saline to the hub of the extension tube to be used for power injection.5.Ensure adequate blood return and flush catheter vigorously with the entire 10 ml of sterile normal saline to ensure lumen patency.Warning: failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.6.Remove syringe and attach power injection device to the catheter using the manufacturer¿s recommendations.7.Conduct study using the power injector, making sure not to exceed the maximum flowrate or pressure limit for the catheter.8.Disconnect the power injection device and flush the catheter again with 10 ml of sterile normal saline.9.Place a new injection/needleless cap on the spectrum turbo-ject picc, flush and lock the catheter with saline or heparinized saline per institutional protocol.¿ how supplied ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if packaging is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of device master record, device history record, and device failure analysis, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the available information, no device returned, and the results of the investigation, cook has concluded that the root cause is related to inadequate flexural strength in a previous hub design change.This product failure was previously investigated under capa 154487.The capa investigation found that the root cause is related to inadequate flexural strength in a previous hub design change.The investigation further found that the devices were manufactured to specification and there was no evidence of lot-related issues.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, 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: COOK SPECTRUM TURBO-JECT
• Type of Device: 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: 12367050
• MDR Text Key: 268120076
• Report Number: 1820334-2021-02052
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00827002345485
• UDI-Public: (01)00827002345485(17)221201(10)13678806
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-NT-ABRM-1111
• Device Lot Number: 13678806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female