LUER LOCK SYRINGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-23 for LUER LOCK SYRINGE manufactured by Unk.

Event Text Entries

[176550089] This is not an error, rather a potential for error. As a nursing department, we were approached by our speech therapy and nutrition departments about a newer recommendation from the iddsi. The recommendation is regarding how to test thickened formulas/liquids to verify they are the correct thickness prior to feeding. The recommendation involves using cl luer lock syringe to count the drips. Our organization has taken a firm stance that we will not support this recommendation using luer lock syringes for a product intended to be administered enterally, even if the intent is not to use that syringe to administer the formula/liquid. When i proposed a request to utilize enfit or enteral syringes, even running a comparison of drops from enfit to luer lock, i was met with resistance. The iddsi stated: "unfortunately, none of the enfit syringes meet the iddsi requirements as they have larger holes in the nozzle. I (and iddsi) appreciate your concerns here and we have created test "funnels" for these reasons. They have identical dimensions to the syringe barrel and nozzle but are described as funnels because they have a funnel-shaped opening for easier filling. They have no plunger, and calling them funnels puts them in the category of kitchen equipment, rather than test or medical equipment. We've produced (b)(4) and our industrial sponsors are helping with consumer "beta-testing" amongst their customers globally. We're hoping these will be produced and distributed by several thickener manufacturers - you could help by ensuring your supplier knows there's a demand for these. In the meantime, removing the plunger from an iddsl-compliant syringe is taking it one step away from it being seen as a conventional syringe; at iddsi we're concerned to absolutely minimize potential risk of misunderstanding re: iv administration- luer tips. Restricting syringes to the kitchen areas, marking them with pens and/or tape is also helpful. "i wanted to raise this as a significant concern that a recommendation is being pushed on an international scale utilizing luer lock products for enteral purposes. It is unclear when the enfit funnels referred to will be ready, but wanted to reach out to see if ismp has a stance on this work. (b)(6), access number: (b)(4). Severity: circumstances or events have capacity to cause error.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092481
MDR Report Key9627305
Date Received2020-01-23
Date of Report2020-01-23
Date Added to Maude2020-01-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameLUER LOCK SYRINGE
Generic NameSYRINGE, PISTON
Product CodeFMF
Date Received2020-01-23
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameENFIT
Generic NameENTERNAL SYRINGE WITH ENTERAL SPECIFIC CONNECTORS
Product CodePNR
Date Received2020-01-23
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-23

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