TIP CAPS,LUER SLIP,STER,YEL, 1 H93866100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for TIP CAPS,LUER SLIP,STER,YEL, 1 H93866100 manufactured by Availmed.

Event Text Entries

[125759243] The actual device was not available; however, a photograph of the sample was provided for evaluation. A visual inspection was performed on the photo and noted two yellow tip caps with black spots seemingly embedded in the side of the luer shaft. A batch review was conducted and a deviation was found related to this reported condition during the manufacture of this lot. The reported problem was verified. The cause of the condition was determined to be manufacturing related. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[125759244] This report summarizes 1 malfunction events. It was reported that black spots were noted on one tips caps, luer slip, sterile, yel, 1. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2018-06953
• MDR Report Key: 8020375
• Date Received: 2018-10-30
• Date of Report: 2018-10-30
• Date Mfgr Received: 2018-09-30
• Date Added to Maude: 2018-10-30
• 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: AVAILMED
• Manufacturer Street: C. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND.
• Manufacturer City: TIJUANA, BAJA CALIFORNIA 22444
• Manufacturer Country: MX
• Manufacturer Postal Code: 22444
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TIP CAPS,LUER SLIP,STER,YEL, 1
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2018-10-30
• Model Number: NA
• Catalog Number: H93866100
• Lot Number: 60087008
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AVAILMED
• Manufacturer Address: TIJUANA, BAJA CALIFORNIA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-10-30