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 Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: spectrum turbo-ject single lumen minocycline/rifampin bedside power-injectable picc.Pma/510(k): k100974.(b)(4).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 a spectrum turbo-ject single lumen minocycline/rifampin bedside power-injectable picc (peripherally inserted central catheter) was inserted on (b)(6) 2019 in a (b)(6) old patient for bi weekly lab draws and iv medication regimen.On (b)(6) 2019 it was reported the ¿picc line broke under the hub¿.The catheter was removed and a new picc was successfully placed.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
There has been no new event information received since the last report.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.A visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also completed including a review of complaint history, device history records, drawings, instructions for use, and quality control data.The complainant returned one single lumen 3.0fr picc line in a used condition.An adapter was present on the hub.Biomatter was present on the device.At the hub, it was noted the extension tubing was partially separated at the hub/tubing junction.No other surface damage on the device was noted.The length of extension tubing was measured from the hub to the manifold.The extension tubing outer diameter was also measured.Both measured to be within manufacturing specifications.Investigators observed the reported failure mode.The device was partially separated, but it was not out of specification for any of the attributes measured.There is no evidence to suggest that the device was not manufactured to current specifications.The device history records (dhr) for the device lot and picc component lot were reviewed.There were no relevant non-conformances noted in the records.Additionally, there have been no other complaints received on the complaint device lot.There is no information regarding care and maintenance of device.It is not known what other fluids were infused through the line or how often the line was accessed.There is no information regarding how the clamp was used, clamping too close to the hub could potentially weaken the fitting causing leaking or breaking.It is unknown if the catheter was accessed for power injection and if so, what psi the pressure was set at.The instructions for use (ifu) advises maximum pressure to be set at or below 325psi.There is no information regarding patient activity, inadvertent pulling on device could weaken the line and fitting.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the device failure analysis, cook has concluded that the failure mode for the device complaint was that the tubing split at the hub.The cause was not established.Measures are in progress to address this failure mode.The appropriate internal personnel have been notified and we will continue to monitor 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
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8535358
• Report Number: 1820334-2019-00943
• Device Sequence Number: 14061116
• Product Code: LJS
• UDI-Device Identifier: 00827002237070
• UDI-Public: (01)00827002237070(17)200723(10)9274516
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 07/23/2020
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-40NT-ABRM-1110
• Device Lot Number: 9274516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 MO