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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  Injury  

Event Description

It was reported that an unknown patient required the placement of a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set on (b)(6) 2023.The catheter was sutured in the right femoral vein.During patient care, it was reported that the catheter came out of the patient.The sutures were found to be intact; however, the suture holes of the catheter hub were noted to be "broken," the complaint device was then removed, and the patient required a new cvc insertion to maintain access.Additional information regarding event details has been requested but is currently unavailable.

Manufacturer Narrative

D1 - device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.E1 - customer (person): postal code: (b)(6).E3 - 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that the suture wing from a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set broke.On (b)(6) 2023, the catheter was placed in the patient¿s right femoral vein and was secured to the patient with suture at the suture wing.On (b)(6) 2023, the catheter dislodged during patient care.It was discovered that the suture wing holes were split; the sutures were still intact in the patient.As a result, the patient required an additional procedure to replace the catheter.No other adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, quality control procedures, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, both suture holes were confirmed to be ripped/cracked.The thickness of the suture wing and diameter of each suture hole was measured and were determined to be in specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ctulmabrm_rev7 is packaged with this device.The product ifu states the following in consideration of the reported failure mode: "precautions: do not cut, trim, or modify catheter or components prior to placement intraoperatively.Patient movement can cause catheter tip displacement.Use should be limited to controlled hospital situations.Catheters placed from either a jugular or subclavian vein have demonstrated forward tip movement of 1-3 cm with neck and shoulder motion.Instructions for use: 9¿ winged hub can now be sutured into place.If catheter is not introduced to its full length, additional suture should be carefully placed around catheter and affixed to the skin at entry site (if movable suture wing is not included).This will help prevent backward or forward catheter movement.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu, and returned device suggests that the torn suture wing was manufactured to specification.At this time, there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a component failure without any design or manufacturing deficiency contributed to this incident.The patient's activity level is unknown.Its possible that the suture wing holes tore during movement of the patient.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.

• Type of Device: 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: 17491426
• MDR Text Key: 320783597
• Report Number: 1820334-2023-01049
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UQLM-1001J-ABRM-HC-RD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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