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

Catalog Number HASC-5.0-ABRM

Device Problems Break (1069); Crack (1135); Fitting Problem (2183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional common name/product code information: foz catheter, intravascular, therapeutic, short-term less than 30 days foz.Occupation: purchasing agent.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 that a spectrum cuffed has with abrm "broke off".Additional information regarding the patient, device, and event has been requested but is currently unavailable.

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.

Event Description

In additional information received on 23apr2021, it was reported that the device was indwelling for 2+ years.While at home, the hub developed a crack and the catheter needed to be replaced.

Event Description

In additional information received on 25aug2021, it was reported that the device was placed in the left internal jugular (ij) for the administration of long term tpn.The device was in place for approximately 2 years.The device was secured to the patient with a cuff and tape/dressing.The patient was able to perform normal daily activities.It was confirmed that the hub of the device had cracked.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b3, b5, d4- product lot # (mdr), d4- expiration date, d4- product lot #, d4- udi, d6, d9, h6- annex e, h6- annex a.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Gundersen health systems informed cook on 01apr2021 of an incident involving a spectrum cuffed has with abrm (rpn: hasc-5.0-abrm, lot number 9348924).It was reported that the device was indwelling for 2+ years.While at home, the hub developed a crack and as a result, the catheter needed to be replaced.Reviews of the complaint history, device history record (dhr), quality control, specifications, 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 (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot (9348924) revealed no recorded non-conformance's relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: precautions: ¿if lumen flow is impeded, do not force infection or withdrawal of fluids.Notify attending physician immediately.¿ catheter maintenance: ¿before using catheter lumen already locked with heparin, lumen saline.Lumen should be flushed with normal saline between administration of different infuscate.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing contributed to this incident.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 Description

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

• Brand Name: SPECTRUM CUFFED HAS WITH ABRM
• 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: 11640557
• MDR Text Key: 264791044
• Report Number: 1820334-2021-01105
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K021557
• 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,Followup,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Catalogue Number: HASC-5.0-ABRM
• Device Lot Number: 9348924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female