FDA Adverse Event Malfunction Summary report: N

IRRISEPT

MDR report key: 12916154 · Received December 1, 2021

Report

Report Number
MW5105699
Event Type
Malfunction
Date Received
December 1, 2021
Report Date
August 5, 2021
Manufacturer
IRRIMAX CORPORATION
Product Code
FQH
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
*

Narratives

Description of Event or Problem · 0

GENERAL QUESTION: GENERAL SURGERY SERVICE HAS APPARENTLY BEEN USING IRRISEPT (CHLORHEXIDINE GLUCONATE PRODUCT) TO FLUSH THEIR JP DRAINS. THEY ARE HAVING NURSES DRAW THE FLUS SOLUTIONS UP IN A LUER LOCK SYRINGE TO ATTACH TO THE DRAIN. OUR CONCERN IS THE RISK THAT THIS MAY INADVERTENTLY BE ADMINISTERED AS AN IV MED SINCE IT IS IN A LUER LOCK SYRINGE. IRRISEPT IS NOT CONSIDERED A DRUG AND THEREFORE PHARMACY IS NOT INVOLVED IN OBTAINING/DISPENSING THIS PRODUCT. THERE ARE SOME LABELS THAT THE NURSING UNIT HAS PRINTED OFF, BUT WE HAVE NO WAY OF CHECKING THAT THE SYRINGES HAVE BEEN APPROPRIATELY LABELED. HAVE YOU EVER LOOKED INTO JP DRAINS AND TYPES OF STOPCOCKS THAT ARE ATTACHED TO THEM? HAS THERE BEEN A STATEMENT ABOUT USING IRRISEPT DRAWN INTO LUER LOCK SYRINGES FOR ADMINISTRATION? WE ARE IN THE PROCESS OF LOOKING INTO WHAT STOP COCK IS BEING USED (ADAPTER ASPIRATION FLUSH WITH LUER LOCK?) WITH PLAN TO HAVE NON-LUER LOCK ADAPTERS AVAILABLE FOR USE INSTEAD. THANK YOU IN ADVANCE FOR ANY INSIGHT. REPORTER'S RECOMMENDATIONS: EVENT JUST REPORTED. DISCUSSING PROVIDING LARGE, COLORFUL "FOR IRRIGATION ONLY" STICKERS FOR RNS TO USE UNTIL THIS GETS SORTED OUT. ASKED FOR TYPE OF ADAPTER BEING USED THAT A LUER LOCK SYRINGE WOULD BE ABLE TO CONNECT TO. RECOMMENDED INVESTIGATING NON-LUER LOCK ADAPTOR/STOCK COCKS WHICH CAN BE USED WITH JP DRAINS. DISCUSSED IF PHARMACY NEEDS TO "DISPENSE" PREPARED SYRINGES OF IRRISEPT FOR PROPER LABELING, ETC. INCOMPATIBILITY: PHYSICAL; PPT, SEPARATION OR INCOMPATIBLE WITH TUBING, ETC. DISPENSING DEVICE INVOLVED INADEQUATE SAFEGUARDS. CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1805196 IRRISEPT LAVAGE, JET FQH IRRIMAX CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 Unknown