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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D1 - brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set 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 that a fly-like object was found inside the sterile package of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.The fly-like object was reportedly found in the gauze.The components did not make patient contact.The procedure was completed with a different gauze package.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that on 19feb2024, the gauze in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray had a fly in it.The device did not make patient contact.The procedure was completed by using a different gauze package.The patient did not experience any adverse effects or require any additional procedures due to this event.Reviews of the documentation, including the complaint history, device history record, quality control procedures, instructions for use, as well as a visual inspection of the returned device, were conducted during the investigation.Cook received a few pieces of gauze from the customer.Visual inspection of the returned device confirmed that an insect was present.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 device history record (dhr) for the reported complaint device lot revealed no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling, the product ifu, [c_t_ulmabrm_rev4] ¿spectrum and spectrum glide central venous catheters,¿ provides the following information to the user related to the reported failure mode: how supplied: ¿do not use the product if there is doubt as to whether the product is sterile.¿ evidence gathered upon review of the dmr, dhr, product labelling and returned device suggests that the device was manufactured out of specification.There is no evidence of additional nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that the cause of this event is a quality control deficiency.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.

• 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: 18852040
• Report Number: 1820334-2024-00299
• Device Sequence Number: 20654234
• Product Code: FOZ
• UDI-Device Identifier: 00827002440159
• UDI-Public: (01)00827002440159(17)250131(10)15580578
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-501J-RSC-ABRM-HC-FST
• Device Lot Number: 15580578
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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