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

Model Number N/A

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: reported as unsure but possibly a day or two before (b)(6) 2021. Device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set. Rpn: c-uqlm-1001j-rsc-abrm-hc-rd-au. Initial reporter occupation: unknown. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that red particulate matter was observed while flushing the lumen of a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set. The spectrum 5 lumen central venous catheter was being flushed prior to insertion when red particles were observed to be coming from the catheter. From a photo provided, these particles could also be seen adhering to the outside of the catheter. A new like device was opened and checked for particles. As there were no particulate matter present, the replacement device was used to complete the procedure successfully. It was noted that the replacement device was most likely from the same lot. The patient did not experience any adverse effects due to this occurrence.

• 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: 11852212
• MDR Text Key: 266890119
• Report Number: 1820334-2021-01363
• 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: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Lot Number: 13333179
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No