MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number G56553

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

As reported, foreign substance (hair) was found inside of the packaging of an unused device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.

Manufacturer Narrative

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

Event summary: as reported, foreign substance (hair) was found inside of the packaging of an unused device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One cxi support catheter was returned for investigation.A hair-like fiber was noted inside the sealed packaging, indicating the device was manufactured out of specification.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ based on the available information, cook has concluded that a manufacturing/quality control deficiency contributed to this event.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of 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.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• 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: 14999306
• MDR Text Key: 303955202
• Report Number: 1820334-2022-01200
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002565531
• UDI-Public: (01)00827002565531(17)250417(10)NS14671387
• Combination Product (y/n): N
• PMA/PMN Number: K122796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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
• Device Model Number: G56553
• Device Catalogue Number: CXI-2.6-18-150-ANG
• Device Lot Number: NS14671387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2022
• 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