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	Break (1069); Unraveled Material (1664); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.Initial reporter name and address: (b)(6).Occupation: risk management.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 the guidewire included in a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set broke during a central line insertion procedure on an unknown patient.Upon removal of the dilator during placement, it was noticed that the guidewire was broken.The physician was able to remove the wire from the patient entirely and complete the procedure successfully.The physician was reported to have experienced blood and bodily fluid exposure from a sharp that resulted from the broken wire.The patient did not experience any adverse effects due to this occurrence.Additional information regarding patient and event details has been requested, but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: b5, d9- product received on.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
In additional information received on 30jun2022, it was confirmed that the physician did experience a blood and body fluid exposure due to the wire break.In response to the incident, blood and body fluid protocols for the facility were followed.
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
Correction: h6 (annex a, annex e and annex f).Investigation ¿ evaluation.(b)(6) hospital (canada) informed cook that on (b)(6) 2022 the guide wire in a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set (rpn: c-uqlm-1001j-rsc-abrm-hc-rd; lot 14496413) broke during a procedure.The physician was able to remove the guidewire entirely from the patient and complete the procedure.The physician suffered a blood and body fluid exposure directly related to the incident.It was reported that the patient did not have any apparent harm.In response to the incident, blood and body fluid protocols for the facility were followed.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.Cook received one used wire guide.The wire was returned in two segments.At 26.2cm, a portion of the safety was protruding.A kink, located on the second segment, was at approximately 30.2cm from the large curved portion.The separation/uncoiling was at 32cm.The outer diameter of the wire guide measured within specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record for lot 14496413 the sub assembly lot (ic14325087) and records no non-conformances.A database search for complaints on the reported lot found no additional complaints.The information provided upon review of dmr, dhr, and device failure analysis, 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: precautions ¿do not cut, trim or modify catheter or components prior to placement or intraoperatively.¿ instructions for use ¿if resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.¿ how supplied ¿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 wire guide was manipulated inside the needle, but cook is unable to confirm this.It was reported that the blood and body fluid exposure event was caused by the broken guide wire.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: 14603627
• Report Number: 1820334-2022-01003
• Device Sequence Number: 5064466
• Product Code: FOZ
• UDI-Device Identifier: 00827002515390
• UDI-Public: (01)00827002515390(17)241214(10)14496413
• Combination Product (Y/N): Y
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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: 12/14/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UQLM-1001J-RSC-ABRM-HC-RD
• Device Lot Number: 14496413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 08/23/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/01/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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