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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE

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SYRINGE Back to Search Results
Lot Number 2016-1060T
Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 08/24/2017
Event Type  Injury  
Event Description
After mixing vivitrol and injecting the patient with the supplied manufacturers needs; the solution clogged and occluded the needle. Needle had to be taken out of the patient and a non-manufacturer needle placed on syringe and patient re-injected and medication delivered. Once removed from the patient the syringe was still clogged and plunger could not be moved to intake air or to expel medication. Needle had to be changed completely. This was the second time in a row that has happened with vivitrol. I checked other va clinics in our system and this is occuring at our other locations in and around (b)(6). The lot numbers of the ones i gave that malfunctioned are 2016-1060t and 2017-1007t. This does not occur with any of the other injectable medications that we give at the clinic. Dose or amount: 380 mg. Frequency: monthly. Route: intramuscular. Dates of use: (b)(6) 2017. Diagnosis or reason for use: opioid dependence. Is the product compounded: yes. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: no. Event reappeared after reintroduction: yes. (b)(6).
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Type of DeviceSYRINGE
MDR Report Key6830186
MDR Text Key84095456
Report NumberMW5071820
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Lot Number2016-1060T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/30/2017 Patient Sequence Number: 1