MAUDE Adverse Event Report: TYCO HEALTHCARE / CARDINAL HEALTH KENDALL MONOJECT 1 ML LUER LOCK SYRINGE [TUBERCULIN]; SYRINGE, PISTON

Lot Number 000903

Device Problems Product Quality Problem (1506); Shipping Damage or Problem (1570)

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

Event Date 03/30/2021

Event Type  Injury  

Event Description

I receive infusions of a medication at home every two weeks to keep a serious and potentially life-threatening disease under control.For that, i have a central venous catheter, which can be a source of blood infections if i use products that are not sterile.I have to push or infuse iv medications prior to that infusion in order to prevent side effects that would cause me (and have in the past caused me) to be hospitalized.One of those medications requires a 1 ml luer lock syringe (slip tip may also work) because it is a high potency medication, and my dose is 0.12 ml.I also have serious and potentially life-threatening side effects if i receive too much of that iv medication.I have been told that, due to covid-19, 1 ml syringes are being diverted for use in vaccination.In (b)(6), i received 1 ml luer lock syringes in single-use packaging made by tyco healthcare.Tyco healthcare was dissolved/purchased by covidien in 2007, and then divested to cardinal health a few years ago.The syringes that i was sent (from (b)(6) to (b)(6)) by a specialty pharmacy owned by (b)(6) were at least 10 years old and potentially up to 13 years old, and the packaging was visibly yellowed.Due to their age, the packaging did not have manufacturing or expiration dates.This means that they likely were no longer sterile and could have caused a blood infection (which could cause severe disability or death from sepsis and/or septic shock) through colonization of my central line.Because i have used medical devices for such a long time, i was aware that tyco has not existed for a very long time.Unfortunately, most patients and home health nurses would not be aware of this, and there was no way to tell from the packaging how old the syringes were.Because i did not have safe syringes to use, my infusion was delayed, which caused the symptoms of my underlying disease to worsen.Additionally, the specialty pharmacy then sent 1 ml slip tip syringes that were approximately 10 years old, based on the packaging (made by bd).After i refused to use those for the same reason and had further delay in my infusion, the company told me that they were unable to get 1 ml syringes.They were only able to send me 3 ml syringes.As a result, since (b)(6) 2021, i have not gotten an accurate dose of an iv pre-medication, which is making me sick (and potentially could result in hospitalization or death if i accidentally draw up too much of that medication).When i contacted cardinal health to ask them whether the syringes were safe to use (since i initially wasn't given another option by the specialty pharmacy), they would not talk to me or answer my question because i had not ordered the syringes directly from them.Instead, they hung up on me twice after i asked if it was safe to use the syringes.Given that the specialty pharmacy thought it was acceptable to send these products to me, there was no way for me as a consumer to determine whether the syringes manufactured by tyco healthcare were safe to use.Only have lot number, "because of how old these are." fda safety report id# (b)(4).

• Brand Name: KENDALL MONOJECT 1 ML LUER LOCK SYRINGE [TUBERCULIN]
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): TYCO HEALTHCARE / CARDINAL HEALTH
• MDR Report Key: 11938341
• MDR Text Key: 254864203
• Report Number: MW5101698
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/01/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 000903
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other