• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TYCO HEALTHCARE / CARDINAL HEALTH KENDALL MONOJECT 1 ML LUER LOCK SYRINGE [TUBERCULIN] SYRINGE, PISTON Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKENDALL MONOJECT 1 ML LUER LOCK SYRINGE [TUBERCULIN]
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
TYCO HEALTHCARE / CARDINAL HEALTH
MDR Report Key11938341
MDR Text Key254864203
Report NumberMW5101698
Device Sequence Number1
Product Code FMF
Number of Events Reported1
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 Received06/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number000903
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/03/2021 Patient Sequence Number: 1
-
-