MAUDE Adverse Event Report: ENFIT ENTERAL SYRINGES; ENFIT SYRINGES

Device Problems Application Program Problem: Dose Calculation Error (1189); Inaccurate Delivery (2339); Application Program Problem: Medication Error (3198)

Patient Problems Overdose (1988); Underdose (2542)

Event Type  No Answer Provided  

Event Description

I am sending this message to report a problem with the new enfit enteral syringes.This design creates the potential for the administration of inaccurate medication doses, although the degree of inaccuracy may be different per manufacturer.Below are potential scenarios where inaccurate doses are delivered.Not that technique is important with the enfit design, and the rn/parent is not supposed to remove air from the tip of the syringe.An enfit syringe is used but the medication is administered orally or added to formula without attaching to an (b)(6) compliant device: the syringe will deliver an 0.15 ml underdose.An enfit syringe is used, but rn fills the tip with medication and administers it by attaching to an(b)(6) compliant device: the syringe delivers an 0.07-0.15ml overdose.An enfit syringe is used, but rn fills the tip with medication and administers it po/adds to feeds not attaching to (b)(6) compliant device: the syringe delivers an 0.07-0.15 ml underdose patient populations affected will be: any patient on an enteral medication where the volume is <3ml (potential for >5%inaccuracy).Pediatric/neonatal patients in particular.Patients on high-risk medications (digoxin, potassium, morphine, etc.).Patients on medications where therapeutic levels are important (seizure medications).Patients on concentrated medications.Patient receiving medications via tube, but are working towards po administration ( they will receive variability of dosages depending on route of administration).Hurdles that institutions must face: determining whether both oral and enfit syringes should be stocked in pharmacies, and when each should be used.Determining what syringe should be used for prepacking enteral medications (enfit or oral syringes?).Coordinating on discharge what syringes should be used at home; educating retail pharmacies as well as families so the appropriate syringe is used.Educating physicians to order specific routes (po vs.Gt/ngt) so pharmacies know what syringe to use (inpatient as well as outpatient).Address company to company variability in enteral delivery products (mixing / matching products could create greater or more variable inaccuracies).Address pharmacy workflow where previously batches were streamlined using 1 syringe type (now we would use separate syringes for specific routes?).Address institutional workflow inefficiency: by changing the route from oral to ng/gt the order number changes and the old dose potentially no longer scans.Rn will need a replacement dose in a different syringe, duplicating work and creating delays; the initial dose is wasted.Our facility is a pediatric hospital; the introduction of the enfit design creates a huge problem due to the large number of doses <3ml.Our hospital's enfit implementation group recently listened to the (b)(6) enfit webinar, but this topic was not mentioned.We would appreciate any recommendations on how to address this issue.(b)(6).

• Brand Name: ENFIT ENTERAL SYRINGES
• Type of Device: ENFIT SYRINGES
• MDR Report Key: 4699889
• MDR Text Key: 19352881
• Report Number: MW5042117
• Device Sequence Number: 1
• Product Code: PIF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1