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 Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scalpel included in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray was observed to be rusted prior to a central venous catheter placement procedure.The catheter tray was discarded and a new like device was used.The complaint device did not make patient contact.No adverse effects have been reported due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Brand name (device name): cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Device information (catalog #) - rpn: c-utlmy-701j-abrm-hc-ihi-fst-a-rd.Occupation: buyer.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b3 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
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: on 19sep2022, a representative of (b)(6) (united states) informed cook that the scalpel in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray (rpn: c-utlmy-701j-abrm-hc-ihi-fst-a-rd; lot number: 14553056) was rusted.When the kit was opened, they noticed the scalpel had rusted.The kit was discarded, and another kit was obtained to complete the procedure.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedure of the complaint 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.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 dhrs for the reported complaint device lot 14553056 and the related subassembly lots revealed no related non-conformances.A databases search for complaints on the reported lot found one additional complaint reported from the field reported by the same customer on the same device about a different, unrelated failure.The information provided upon review of device master record and device history record does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_rev7] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: how supplied: ¿store in a dark, dry, cool place.Upon removal from packaging, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, cook concluded the cause of the failure could not be established.It is possible that the lidocaine broke inside the packaging causing the scalpel to rust and/or the shipping or storage conditions contributed to the rust.However, cook cannot confirm either of these possibilities and there is no indication of manufacturing or design deficiencies.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.

• 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: 15538278
• Report Number: 1820334-2022-01578
• Device Sequence Number: 17883167
• Product Code: FOZ
• UDI-Device Identifier: 00827002498037
• UDI-Public: (01)00827002498037(17)240701(10)14553056
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081113
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2023

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: 07/01/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD
• Device Lot Number: 14553056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 02/28/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/16/2022; 03/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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 Sex: Unknown