MAUDE Adverse Event Report: COVIDIEN COVIDIEN HYPODERMIC SAFETY NEEDLE ; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 832368

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem Underdose (2542)

Event Date 02/22/2019

Event Type  malfunction  

Event Description

It all started (b)(6) 2019.We had recently switched to covidien hypodermic safety needle 25g x 5/8 in.Most of the sq meds we give are thick and given sq slowly.Example procrit, velcade.We started having leaking around the hub where we attach the needle to the syringe.This is leading to unk dosing of lifesaving medications.It is happening with more than one lot, regardless of which nurse administers the medication.We reached out to cardinal health (b)(6) 2019.They sent a container with a sase, which i placed the defective needles in the sent back 02/28/2019.On 04/24/2019, i received an email stating that had not received the samples.On 04/25/2019 i sent another batch of defective needles back to them.On 07/30/2019 i reached out to cardinal to inquire if they had an answer or solution to what caused certain batches of needle to leak.I received an email stating the inquiry had not finished and they would try and expedite it.I am reaching out to you out of frustration and concern for our pts' wellbeing.Also, we have given a sufficient amount of time for a solution to be found and reported.We need an answer to the issue with these needles and/or they need to be pulled from use until that happens.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN HYPODERMIC SAFETY NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 9172534
• MDR Text Key: 161856124
• Report Number: MW5090300
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 832368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other