MAUDE Adverse Event Report: CENTURION MEDICAL PRDOUCTS / MEDLINE INDUSTRIES, INC. PEDI CATH KIT, 5FR, SOFT WITH SURGICAL LUBE; TRAY, CATHETRIZATION, STERILE URETHRAL WITH OR WITHOUT CATHETER (KIT)

Model Number CKF155L

Device Problems Fungus in Device Environment (2316); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2020

Event Type  malfunction  

Event Description

As part of my work related to pt care and supply logistics in a military hosp, i noticed a centurion pediatric catheter kit 5fr soft with surgical lube appeared to have mold and yellow/brown dried liquid on the inside of the package.The package is unopened and not expired; exp date is set for 10/31/2020.I have not opened the packet to investigate, but i believe that the internal packet of iodine was broken and leaked out.This allowed for a growth to start inside the otherwise sterile package.The rest of the lot seemed uncontaminated.The lot number is 2018120690.The reorder number for the centurion medical product is ckf155l.I was recently informed to create this report regarding the event.Fda safety report id#.(b)(4).

• Brand Name: PEDI CATH KIT, 5FR, SOFT WITH SURGICAL LUBE
• Type of Device: TRAY, CATHETRIZATION, STERILE URETHRAL WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CENTURION MEDICAL PRDOUCTS / MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9847754
• MDR Text Key: 184178539
• Report Number: MW5093804
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: CKF155L
• Device Lot Number: 2018120690
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1