TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE UROT1070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE UROT1070 manufactured by Medline Industries Inc.

Event Text Entries

[184086217] This facility saw multiple patients with injury related to the 14fr medline catheter. Post insertion attempts patients developed different symptoms from hematuria, false passages, urethra trauma. These patients required cystoscopies due to the trauma/injury. Some required a foley post discharge from the medical center. Manufacturer response for tray cath 400ml um with slide tap 14fr silicone foley safesecure custom, (brand not provided) (per site reporter). Medline's response was that they had not seen these issues at other facilities. We are returning unused product to medline.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9853356
• MDR Report Key: 9853356
• Date Received: 2020-03-19
• Date of Report: 2020-01-28
• Date of Event: 2020-01-15
• Report Date: 2020-01-29
• Date Reported to FDA: 2020-01-29
• Date Reported to Mfgr: 2020-03-19
• Date Added to Maude: 2020-03-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE
• Generic Name: KIT, URINARY DRAINAGE COLLECTION
• Product Code: PPG
• Date Received: 2020-03-19
• Catalog Number: UROT1070
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINE INDUSTRIES INC
• Manufacturer Address: 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	2020-03-19