KATETERVEN.CV.MONT. SL.1-5-100 90 805 1S - 10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2015-10-29 for KATETERVEN.CV.MONT. SL.1-5-100 90 805 1S - 10 manufactured by Unomedical S.r.o..

Event Text Entries

[29849583] Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a). Evaluation conclusions are reflected.
Patient Sequence No: 1, Text Type: N, H10

[29849584] Complainant reports "2 of 10 valve leaked, mainly on the white side when it was closed, sometime at the bottom. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3005778470-2015-31062
• MDR Report Key: 5188055
• Report Source: FOREIGN,OTHER
• Date Received: 2015-10-29
• Date of Report: 2014-02-27
• Date Mfgr Received: 2014-02-27
• Date Added to Maude: 2015-10-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JEANETTE JOHNSON
• Manufacturer Street: 211 AMERICAN AVE
• Manufacturer City: GREENSBORO NC 27409
• Manufacturer Country: US
• Manufacturer Postal: 27409
• Manufacturer Phone: 3362973009
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KATETERVEN.CV.MONT. SL.1-5-100
• Generic Name: CONNECTOR, CATHETER
• Product Code: GCD
• Date Received: 2015-10-29
• Returned To Mfg: 2011-09-06
• Model Number: 90 805 1S - 10
• Lot Number: 409200
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNOMEDICAL S.R.O.
• Manufacturer Address: PRIEMYSELNY PARK 3 MICHALOVCE, 07101 LO 07101

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-10-29