JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
Received Oct 14, 2014 · Event occurred Sep 26, 2014
Report 9680904-2014-00040 · MDR key 4169195
Device
Product problems
- Device Packaging Compromised
Patient
Not reported
- Cellulitis
Narrative
Description of Event or Problem
PACKAGING CRUMBLING. DOCTOR STATED THAT AFTER USING A NEEDLE IN THE CRUMBLED PACKAGE THE PATIENT DEVELOPED A CELLULITIS INFECTION AT THE BONE MARROW SITE. "CELLULITIS AT BONE MARROW SITE, DON¿T KNOW IF DIRECT CORRELATION." ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 VIA (B)(4) FROM (B)(6): MEDICAL INTERVENTION TO THE PATIENT WAS ANTIBIOTIC ADMINISTRATION. OUTCOME WAS UNCOMPLICATED RESOLUTION. WE HAVE SAMPLES AVAILABLE FOR EVALUATION (QUANTITY ¿(B)(4) FROM (B)(4) DISTINCT LOT NUMBERS).
Additional Manufacturer Narrative
(B)(4). UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.PLEASE NOTE: LOT NUMBERS ALSO REPORTED BY CUSTOMER AS POTENTIAL AFFECTED PRODUCT ARE: D11030036, (B)(4).
Additional Manufacturer Narrative
(B)(4): SEVENTEEN (17) SAMPLES WERE RECEIVED: NINE (9) FROM LOT# 0000310164, FOUR (4) FROM LOT# D11030036, TWO (2) FROM LOT# D10050760, ONE (1) FROM LOT# D09111607 AND ONE (1) FROM LOT# D10050791. IN ALL 17 CASES, FRAGILITY AND TEARING OF THE PACKAGE COULD BE NOTED. FAILURE MODE COULD BE CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR THEIR RELEASE WERE MET. MATERIAL IS CONSIDERED TO BE RELATED TO REPORTED FAILURE MODE. THE MOST PROBABLE ROOT CAUSE COULD BE RELATED TO MATERIAL PROVIDED.