ARROW CONTINUOUS NERVE BLOCK KIT
Received Jul 31, 2014 · Event occurred Jul 1, 2014
Report 1036844-2014-00304 · MDR key 4029938
Device
Generic name
Anesthesia Conduction Kit
Manufacturer
Arrow Intl., Inc.Catalog number
FB-19608-K
Lot number
23F14A1695
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT ALLEGES THA THE LIDOCAINE AMPULE "CRUSHED" WHEN THE TECH TRIED TO OPEN IT. THE ALLEGED DEFECT OCCURRED DURING A NERVE BLOCK PROCEDURE ON A PATIENT. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED BROKEN PIECES OF A MEDICATION AMPULE. THE RETURNED GLASS PIECES WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT NOT ALL PIECES APPEAR TO HAVE THEN RETURNED. THE TOP OF THE VIAL WAS RETURNED INTACT AND BROKEN CLEANLY AT THE SCORE LINE. A DEVICE HISTORY (DHR) REVIEW WAS PERFORMED ON LIDOCAINE AMPULES WITH NO RELEVANT FINDINGS. THE REPORTED COMPLAINT OF AMPULE CRUSHED UPON OPENING WAS CONFIRMED BASED ON THE CONDITION OF THE SAMPLE RECEIVED. A PORTION OF THE MEDICATION AMPULE WAS RETURNED IN SEVERAL PIECES. HOWEVER, THE TOP THAT WAS RETURNED APPEARS TO HAVE BROKEN ALONG THE SCORE LINE AS INTENDED, INDICATING THAT THERE ARE NO ABNORMALITIES IN THE SCORE LINE. THE ENTIRE AMPULE WAS NOT RETURNED. A DHR REVIEW WAS PERFORMED ON THE LIDOCAINE AMPULES WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED A CONCLUSION CODE COULD NOT BE CHOSEN AS THE COMPLAINT WAS CONFIRMED, HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.