MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL 3 SPRING RESERVOIR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

Event Description

I am a neuroscience aprn at (b)(6).We have identified a manufacturer product defect with the cardinal 3 spring reservoir.We notified cardinal 8 months ago to ask for a solution as these devices go into the body and more specifically the spine for certain patients.The device easily detaches where the catheters connect between the reservoir and the patient line.Otherwise known as the "y" connection.Since we initially contacted cardinal, we now have a total 13 reported detachments.An rn was splashed with bio and a cervical spine patient developed an ssi.We've shared all of this with cardinal and their response is to ask that our staff "tape" the connection or push the connection further together.Bottom line, this only slows down the disconnection making it 3 tugs vs.1 to disconnect.Additionally, they are now asking to retain the drains for their evaluation and document the lot number.The product does not even have a lot number on the actual drain and we do not feel it is safe to maintain bio for them to evaluate what they already know is an issue per their rep.We have asked repeatedly why the product allows for the ability to disconnect as clinically there is no purpose.We have had 4 meetings with cardinal and hosted them at one of our locations to interact with staff to learn firsthand how this affects their practice and patient outcomes.Additionally, our team provided solutions to better the product to minimize disconnecting and they still just offered education.Their head of quality assurance noted they cannot do better at this time as they'd have to shut down production while they build another prototype.Frankly, this is disturbing and emphasizes their priority of financial gain vs a quality product that is safe for patients.Please investigate this product and have it removed from the market until it is improved.Unfortunately, cardinal seems to be one of the only companies to still make this product, so they have the lion's share of the market.We are happy to share more details if needed while of course respecting our patients privacy.Reference report: mw5117303, mw5117304, mw5117305, mw5117306, mw5117307, mw5117308, mw5117309, mw5117310, mw5117311, mw5117312, mw5117313, mw5117314.

• Brand Name: CARDINAL 3 SPRING RESERVOIR
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 16887081
• MDR Text Key: 314833521
• Report Number: MW5117315
• Device Sequence Number: 1
• Product Code: GCY
• 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 Practitioner
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other