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

Model Number G34545

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Brand name: spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.(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 a spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc catheter was found to be split during its scheduled removal.Visual inspection performed by the medical personnel stated the device was split open approximately 3cm.The patient completed treatment over the course of an unknown amount of time with the line placed in arm.As reported, the patient did not experience any adverse effects or require an additional line insertion due to this occurrence.

Manufacturer Narrative

Investigation evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The reported device was returned in a used, damaged condition.There was a 2cm rupture in the catheter near the distal tip.A test wire guide was fed through each lumen, and it was determined that only the white hub lumen of the catheter burst.The catheter was measured shorter than specified, however, it is stated in the ifu that the catheter can be cut down for patient anatomy.Additionally, the proximal end of the catheter was measured and was found to be smaller than specified, however, due to the used and damaged condition of the device, there is not enough evidence to suggest the device was not manufactured to specifications.The device master record was reviewed and there are adequate controls in place to ensure the device was manufactured to specifications.The device history record was reviewed and no related non-conformances were found.No additional complaints have been reported from the product lot.There is no evidence to suggest there are non-conforming devices in house or in field.Reviewing the instructions for use showed that there are descriptions of the maximum flow rates for the specific catheter included with this set, and that with the 4fr double lumen catheter, only the orange hub should be used for power injection.The turbo-ject catheters underwent dynamic burst validation testing to determine the maximum pressures and flow rates that should be used with power injection.The white lumen of this catheter is not supposed to be used with a power injector.It is possible that the white lumen was used with a power injector, against the labeling of the device and the instructions for the 4fr double lumen catheter listed in the ifu.It was stated from the customer that cath-flow, a treatment for occluded catheters, was used several times.It is possible that the lumen was occluded prior to rupture and excess pressure was applied to attempt to remove the occlusion.A definitive conclusion cannot be reached.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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.

• 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
• MDR Report Key: 7660409
• MDR Text Key: 113193674
• Report Number: 1820334-2018-01860
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)190920(10)8579775
• Combination Product (y/n): N
• PMA/PMN Number: K133634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Model Number: G34545
• Device Catalogue Number: UPICDS-4.0-CT-40NT-ABRM-1111
• Device Lot Number: 8579775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2018
• Patient Sequence Number: 1