OLD 5ML CLR EXACTAMED EMEA (H9381105)

Additional Manufacturer Narrative

METHOD CODE: ACTUAL DEVICE NOT EVALUATED. TECHNICAL SUPPORT RECEIVED AN E-MAIL FROM BAXTER EMEA QUALITY REGARDING A COMPLAINT FROM THE UNITED KINGDOM'S CUSTOMER ON OCTOBER 31, 2013. THE COMPLAINANT STATED THAT AN ORAL DRUG WAS ADMINISTERED VIA AN IV LINE USING BAXA 5 ML ORAL SYRINGE. NO PATIENT INJURY OR ILLNESS REPORTED. THERE ARE NO SAMPLES AVAILABLE FOR AN EVALUATION. WE HAVE CONDUCTED AN INVESTIGATION INTO THIS ISSUE AND HAVE DETERMINED THAT OUR DISPENSERS, OLD 5ML CLR EXACTAMED EMEA (H9381105) MEET SPECIFICATIONS AND REQUIREMENTS OF NPSA PATIENT SAFETY ALERT NPSA/2007/19. WE HAVE DETERMINED THE ROOT CAUSE OF THIS ISSUE IS A RESULT OF BD NEXIVA NEEDLELESS ADAPTERS NOT MEETING THE ISO 594 STANDARDS. A WORLDWIDE VOLUNTARY RECALL WAS ANNOUNCED BY BD ON OCTOBER 28, 2009, FOR BD Q-SYTE LUER ACCESS DEVICES AND BD NEXIVA CLOSED IV CATHETER SYSTEMS MAY HAVE FURTHER CONTRIBUTED TO THE CAUSE OF THE INCIDENT. OUR RISK ASSESSMENT OF THESE REPORTED ISSUES SHOW THAT THE POTENTIAL OF PATIENT HARM IS SUFFICIENTLY LOW DUE OT THE FOLLOWING RISK CONTROL MEASURES: 1. ORAL DISPENSERS ARE CLEARLY LABELED FOR ORAL OR ENTERAL USE ONLY. 2. THE CLEAR DISPENSERS HAVE PURPLE PLUNGERS SPECIFICALLY TO COMPLY WITH NPSA ALERT 19 SO THAT THEY ARE IDENTIFIED FOR ORAL/ENTERAL USE. 3. OUR DISPENSERS COMPLY WITH ISO 80369-ANNEX B STANDARDS TO NOT ACTIVATE ANY NEEDLELESS CONNECTOR THAT IS DESIGNED TO ISO 594 STANDARDS. BASED ON AN EVALUATION OF THE PRODUCT RISK MANAGEMENT FILES FOR THESE DISPENSERS, THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED FOR THE DEVICE. DEVICE WAS NOT AVAILABLE.

Description of Event or Problem

TECHNICAL SUPPORT RECEIVED AN E-MAIL FROM BAXTER EMEA QUALITY REGARDING A COMPLAINT FROM THE (B)(6) CUSTOMER ON (B)(6) 2013. THE COMPLAINANT STATED THAT AN ORAL DRUG WAS ADMINISTERED VIA AN IV LINE USING BAXA 5 ML ORAL SYRINGE. NO PATIENT HARM OCCURRED.