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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENFIT SYRINGES; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
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ENFIT SYRINGES; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Description
An inpatient with a g-tube was ordered for a topical compounded pain gel by a chronic pain service consult containing amitriptyline 1% and ketamine 1% in a plo gel base.The gel was packaged into enfit syringes with 1 ml of gel in each, labeled with compound name, and route.Order was written with topical route as well.The patient's nurse accidentally administered the gel per g-tube along with a number of other enteral liquid medications that were due at the same time and also packaged in enfit syringes.Investigation has revealed that it is common practice at many hospitals, compounding pharmacies, and out sources to package liquid or gel topicals in oral syringes.We are currently planning to bring in oral slip tip syringes for this purpose since these were not re-ordered after the switch to enfit which helps differentiate from the more common enfit syringes used at our hospital, however this does nothing to reduce the risk of oral administration.We also package lidocaine-epinephrine-tetracaine this way.We are exploring using medidose cups typically used to repackaged solid oral dosage forms for these low volume topical gels/liquids.We haven't identified safer dispensing devices that allow for accurate measuring, tamper evident sealing, and look very different that enteral syringes.Submission id: (b)(4).(b)(4).
 
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Brand Name
ENFIT SYRINGES
Type of Device
ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
MDR Report Key14257475
MDR Text Key293347829
Report NumberMW5109438
Device Sequence Number1
Product Code PNR
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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