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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: spectrum turbo-ject single lumen minocycline/ rifampin bedside power-injectable picc.Additional product code: foz.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the extension tubing of a spectrum turbo-ject single lumen minocycline/ rifampin bedside power-injectable picc separated from the "orange winged portion," resulting in leakage.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Investigation ¿ evaluation: children hospital of akron notified cook about an issue with the extension tubing in an cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducers (upics-3.0-ct-40nt-abrm-1110 ) from lot 13612175.The extension tubing separated from the batwing hub and leaked.It unknown if there were adverse effects or if the device was replaced.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device 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.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record (dhr) for lot 13612175 and its subassembly and raw material lots and records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook also reviewed product labeling.The product ifu, [t_upicabrmtt_rev1] ¿cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducer,¿ 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 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 spectrum turbo-ject picc lines 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.Dynamic and static pressure test results are shown in the following table.¿ cook spectrum turbo-ject power injectable picc dynamic and static pressure results ¿*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.Power injection procedure 6.Conduct study using the power injector, making sure no to exceed the maximum flow rate or pressure limit for the catheter.How supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the device master record and device history record, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned device, and the results of the investigation, it was determined the cause of this event is related to inadequate device change validation.This product failure was previously investigated under a capa.The capa investigation found that the root cause is related to inadequate flexural strength in a previous hub design change.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.
Event or Problem Description
No additional information regarding the patient and/or event 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: 12807031
• Report Number: 1820334-2021-02492
• Device Sequence Number: 17529795
• Product Code: LJS
• UDI-Device Identifier: 00827002237070
• UDI-Public: (01)00827002237070(17)220915(10)13612175
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-40NT-ABRM-1110
• Device Lot Number: 13612175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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
• Patient Sex: Unknown