MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH MONOJECT ENFIT SYRINGES, 3 ML; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2021

Event Type  Injury  

Event Description

Therapy interruption; i have 2 feeding tubes (button style tubes).Normally, i use non-enfit bd slip tip syringes to flush the extension sets because slip tip syringes are safer and easier to use with small doses of concentrated liquid medications than enfit syringes.Unfortunately, i've had extreme difficulties obtaining those the past few months because mckesson states that they are on backorder.Bd told me that they were on allocation.I instead ordered 3 ml monoject enfit syringes (covidien/cardinal health), which are rx-only medical devices.Someone at the distributor [mckesson, who supplies these on behalf of my enteral supply company] pulled 10 monoject enfit syringes out of a bulk package and placed them in a dirty ziploc-style bag.There is no packaging on or with these items, which means that they easily could have been tampered with or contaminated with any number of pathogens that could cause illness.I believe that these syringes are supposed to be in individual or sealed packaging with specific types of information on that packaging (e.G., adequate instructions for use).These syringes were shipped to me in (b)(4) from a mckesson distribution center in (b)(4), so the syringes traveled in interstate commerce to reach me.I have saved the packing/shipping slip.I will not receive replacements until tomorrow and have been without syringes for my feeding tube since may 7.As a result, a gray film has built up on the extension sets because i am unable to properly flush them.Oral syringes are not compatible with my feeding tube, so i cannot easily procure replacement syringes.Enfit syringes also are too expensive to pay for out-of-pocket.I was told by my enteral supply company that i am not the only patient to have reported this problem with loose syringes in a ziploc-style bag, and the enteral supply company has supposedly repeatedly spoken to mckesson about the issue without resolution.This also is not the first time i have received loose syringes in a ziploc-style bag from mckesson.It happened 6-8 months ago with non-enfit (but rx-only) syringes.I am unable to report this problem to the manufacturer because cardinal health will not speak to a consumer about covidien brand products if they are not ordered from cardinal health/if you are not a business.I did report the problem to the enteral supply company.Fda safety report id# (b)(4).

Event Description

Additional information received from the reporter on (b)(6) 2021 for report mw5101607: i am 100% dependent on tube feeds to stay alive.For the third time in a few months, i've received unwrapped monoject enfit 3 ml rx only syringes.I filed a medwatch report a few weeks ago for the same issue.Mckesson is putting 10 unwrapped syringes in a dirty (b)(6)-style bag and shipping them to me from a warehouse in (b)(6).I have asked my (b)(6) company (who uses mckesson as its distributor) for wrapped syringes because even a minor infection could lead to even more severe disability or death for me, particularly an infection introduced to or affecting my gastrointestinal tract.Because i am not being sent properly packaged rx-only syringes and the company refuses to send product in the packaging that the manufacturer packages it in that prevents tampering, i am not receiving any syringes to flush my feeding tube extension set.Because these are rx-only devices, i cannot purchase them in a store and have no other way to obtain them.(my insurance company pays a per diem payment to the (b)(6) company for bundled tube feeding products, so i also cannot receive these from a different distributor.) as a result, a gray film is building up on the extension set, which is making me sick and causing clogs.This means that i'm unable to eat.Fda safety report id# (b)(4).

• Brand Name: MONOJECT ENFIT SYRINGES, 3 ML
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH
• MDR Report Key: 11900821
• MDR Text Key: 253994188
• Report Number: MW5101607
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/05/2021
• 20 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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