MAUDE Adverse Event Report: MPS MEDICAL, INC. EXTENSION SET, LENGTH 8" MINIBOR

Model Number DB-008-01

Device Problems Crack (1135); Product Quality Problem (1506); Device Damaged Prior to Use (2284)

Patient Problem Unspecified Infection (1930)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

Rn unit supervisor, intensive care nursery reports 0.2 micron filter set male luer lock hub/collar that connects to female end of tubing is cracked/shattered both when connecting and disconnecting.Also, reports cracked/shattered male luer hub/collar right out of the package.Formerly acacia product.Now mps manufactures.Package appears to be of lower quality since change.The nursing staff in the intensive care nursery report is vigilant about iv line infections and had a total of 8 reported infections in the 12 months of 2014.Between january 2015 - march 2015, they reported 8 iv line infections and 1 additional report as of (b)(6) 2015.The nursing staff reviewed all steps in their process and narrowed the focus to this filter set due to change in packaging, noticing the cracking/shattering and product not seeming to be of the same quality as when acacia was manufacturing.Pictures have been taken of the cracked shattered male luer/hub/collars.Dose or amount: none, frequency: daily, route: intravenous.Dates of use: iv line for lipids, tpn and nutrition.Event abated after use stopped or dose reduced: yes.

• Brand Name: EXTENSION SET, LENGTH 8" MINIBOR
• Type of Device: EXTENSION SET, LENGTH 8" MINIBOR
• Manufacturer (Section D): MPS MEDICAL, INC.; brea CA 92821
• MDR Report Key: 4692445
• MDR Text Key: 5644490
• Report Number: MW5042075
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DB-008-01
• Device Catalogue Number: DB-008-01
• Device Lot Number: 091114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other