MAUDE Adverse Event Report: NEOMED, INC. ENFIT; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problems Inadequacy of Device Shape and/or Size (1583); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Our hospital converted to enfit syringes and supplies in xxxx.Since then we have encountered several operational, procurement, and other issues i'd like to share.At our institution, we have opted to convert all oral and enteral syringes to neomed enfit to streamline stock and operations.We order glycerin syringes from an outsourcer for rectal administration, and these syringes need to stay as "slip tip" to allow administration.The adapter for oral administration was stated to be acceptable for rectal use by the vendor, but our neonatal nurses state that its size is too large/oddly shaped to be used in this manner.We purchase some medications from outsourcing pharmacies (eg, acetaminophen from safecor) and they have not yet been able to covert to enfit due to air bubble issues with the low-dose syringes (0.5,1,3,6 ml).Neural bottles do not fit any of the adapters that are supplied.We reached out to neural company to clarify how they recommend drawing up doses using enfit - and they appeared to be unaware and unconcerned about enfit and the pharmacy adapters.There are various sized "air bubbles" that are generated when the neomed small syringe sizes are capped by "pushing" the cap on, rather than "twisting" the cap on.We reached out to neomed to clarify the volume of air.They replied that it will vary based on technique of capping and force of capping syringes, but that it can be a volume of up to 0.4 ml.Not a significant issue for adult doses; but this can pose an issue for neonatal oral doses, and also a challenge for the pharmacist checking the correct volume of a drawn up syringe and a nurse checking the volume of dose in pharmacy prepared syringe before administering.There have been some reported issues with crushed tablets mixed with water being too thick to dry up using rn straw adapter, and a portion of dose being lost.Known and previously reported ismp issue that syringe adapters have dead space issue and result in portion of dose being lost in dead space when using (pertinent for pediatric doses - less of an issue in adults).Thank you taking the time to review this.In particular, if any assistance can be made in getting drug manufacturers and enfit suppliers to address challenges on their end - it would be appreciated.Please feel free to reach out if you'd like further information details.(b)(6); access number: (b)(4).

• Brand Name: ENFIT
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC.
• MDR Report Key: 8239508
• MDR Text Key: 133319365
• Report Number: MW5083046
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1