TIP CAP LUER LOCK EMEA H93864110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for TIP CAP LUER LOCK EMEA H93864110 manufactured by Baxter Healthcare ? Round Lake.

Event Text Entries

[134749890] A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[134749891] This report summarizes 1 malfunction events. It was reported that a tamper-evident luer lock tip cap was potentially contaminated. The reporter stated that they detected the bacterium? Tepidiphilus margaritifer? During? Microbiological controls? Of their compounding unit. The tamper-evident luer lock tip cap was being used at the compounding facility when the bacterium was detected. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-00489
• MDR Report Key: 8294840
• Date Received: 2019-01-31
• Date of Report: 2019-01-31
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2019-01-31
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal Code: 60073
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TIP CAP LUER LOCK EMEA
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2019-01-31
• Model Number: NA
• Catalog Number: H93864110
• Lot Number: 13291
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE ? ROUND LAKE
• Manufacturer Address: ROUND LAKE IL

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-31