MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Rpn: c-utlmy-701j-lsc-abrm-hc-fst-rd.Occupation: nursing services assistant.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 or Problem Description
It was reported the line of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray fractured.On 1(b)(6) 2023, the registered nurse (rn) went to give medicine to the patient.When she went to the clamp, she noticed the line to be bent.She attempted to fix the line but it "snapped," partially breaking.The patient's wife said that at some point the line was caught on his gown.The rn reported the incident to the physician.The physician instructed her to tape the line due to the location of the fracture and told her the patient would be discharged the next day.However, the patient was not discharged the next day, and the patient remained at the medical center with the fractured line until (b)(6) 2023 when he was finally discharged.The fracture of the line was noted to be approximately 1.5 inches from the lock end.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Sidney health center (united states) informed cook that on 13feb2023 the central venous catheter from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray (rpn: c-utlmy-701j-lsc-abrm-hc-fst-rd, lot: 14807675) was broken.On 13feb2023, the registered nurse (rn) went to give medicine to the patient.When she went to the clamp, she noticed the line to be bent.She attempted to fix the line but it "snapped," partially breaking.The patient's wife said that at some point the line was caught on his gown.The rn reported the incident to the physician.The physician instructed her to tape the line due to the location of the fracture and told her the patient would be discharged the next day.However, the patient was not discharged the next day, and the patient remained at the medical center with the fractured line until (b)(6) 2023 when he was finally discharged.The fracture of the line was noted to be approximately 1.5 inches from the lock end.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One used central venous catheter was returned to cook for evaluation.The third extension tube was returned with tape and gauze around the tube.Removal of the tape and gauze confirmed the tube was broken/split.Cook has concluded that the device was manufactured to specification.Additionally, 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 and related subassembly lots revealed no recorded non-conformances 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 there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the repetitive placement of the clamp on the same position on the extension tube contributed to this failure.It is also possible the extension tube was damaged when it caught on the gown or other equipment in the hospital.However, none of these possibilities can be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 or that a death or serious injury occurred; nor is it admission 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
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 16437337
• Report Number: 1820334-2023-00188
• Device Sequence Number: 3199399
• Product Code: FOZ
• UDI-Device Identifier: 00827002478329
• UDI-Public: (01)00827002478329(17)240731(10)14807675
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-701J-LSC-ABRM-HC-FST-RD
• Device Lot Number: 14807675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 120 KG