UNKNOWN BD ECLIPSE¿
Received Oct 18, 2017 · Event occurred Jul 8, 2016
Report 2243072-2017-00179 · MDR key 6960196
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Needle Stick/Puncture
- Needle Stick/Puncture
Narrative
Additional Manufacturer Narrative
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER IS UNKNOWN. (B)(6), UNITED STATES WAS USED AS A DEFAULT. RESULTS: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY REVIEW WAS NOT CONDUCTED BECAUSE A LOT NUMBER COULD NOT BE DETERMINED. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT.
Description of Event or Problem
THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED THAT THERE WAS A NEEDLE STICK WITH A UNKNOWN BD ECLIPSE¿. IT IS UNKNOWN IF THE NEEDLE STICK WAS PRE OR POST USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.