MAUDE Adverse Event Report: CARDINAL HEALTH, INC. CARDINAL HEALTH, COVIDIEN REF8881903002; CONTAINER, LIQUID MEDICATION, GRADUATED

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Event Description

I use covidien monoject 3 mm oral syringes ref 8881903002.I purchased brand new boxes from (b)(4) as well as two other distributors.Each time i got a substandard product made by the same company depicting the same reference number.It turns out the manufacturer decided to make a 90% change to the product so the only thing it has in common with the original product is that it is 3 ml.This not only defrauds customers such as myself, it makes it impossible to find the proper replacement products, because they bypassed fda product licensing, and inspection by putting a completely new product under a old reference number and making believe that it is the same product which in fact is completely different.As it is no longer an oral syringe is now an iv syringe.(b)(6) 2023, md checked eyes for scratches.They should be given a mandatory recall and be forced to re-box the products under a new reference number since it is a new product and remove the word oral and replace it with iv.Since it is no longer the same product.Which, of course defraud both the american consumers, as well as the fda and just to prove my point, i even have one that i stuck a brand-new unused needle on.Reference report #mw5146805, #mw5146806.

• Brand Name: CARDINAL HEALTH, COVIDIEN REF8881903002
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): CARDINAL HEALTH, INC.
• MDR Report Key: 17919968
• MDR Text Key: 325818627
• Report Number: MW5146804
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White