ENFIT SYRINGE 3ML

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for ENFIT SYRINGE 3ML manufactured by Medtronics/covidien.

Event Text Entries

[59906268] Description: regarding the new enfit syringe options. We have some concerns that we would like to make you aware of. Although it is already (b)(6) law, products are not yet available from the companies and our 2 options are medtronics/covidien or neomed/icu medical. Regarding the medtronics/covidien enfit syringes. The 3ml syringe has 1/2 markings in between each number which is not typical or safe practice as you can see how our staff would potentially draw up the incorrect volume. In addition, the 1 ml syringe has a "trailing zero" "1. 0 ml" which is against ismp/tjc recommendations and this could be confused with 10 ml. Medtronics/covidien also does not make a 0. 5 ml syringe at this time which could be problematic for some of our tiny doses of medications. Although all of these concerns have been escalated within their company, we do not have a time frame for if/when these issues would be resolved we still have concern with both companies regarding the outpatient bottle dispensing cap dead space volume and non-safety cap risks. Both companies have not been able to provide us with the dead space volume of the corks but we know the pt would need to remove and replace with a safety cap for safer storage. For medications like chemotherapy, this could increase exposure for pts/parents if they need to clean this with each use. For controlled substances we are concerned about losing medication in the cork and needing to provide "overfill" which is not permitted. (b)(6). When and how was error discovered: when the vendor came to visit (b)(6) to bring samples, the pharmacy team quickly identified these issues. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065970
MDR Report Key6098852
Date Received2016-11-09
Date of Report2016-08-03
Date Added to Maude2016-11-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameENFIT SYRINGE 3ML
Generic NameENFIT SYRINGE 3ML
Product CodePNR
Date Received2016-11-09
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONICS/COVIDIEN

Device Sequence Number: 2

Brand NameENFIT SYRINGE 1ML
Generic NameENFIT SYRINGE 1ML
Product CodePNR
Date Received2016-11-09
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerMEDTRONICS/COVIDIEN


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-09

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