SPECIFIC PATIENT HOME BAG
Received Oct 21, 2010 · Event occurred Sep 26, 2010
Report 6000001-2010-04400 · MDR key 1879094
Device
Product problems
- Break
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6) 2010 AN INCIDENT WHERE THE SYRINGE CODE HAD A HOLE IN IT AND THE PISTON WAS BROKEN WITH THE SPECIFIC PATIENT HOME BAG. THIS INCIDENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Additional Manufacturer Narrative
THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).
Additional Manufacturer Narrative
(B)(4). THE PRODUCT WITH THE ALLEGED DEFECT IS NOT A BAXTER PRODUCT; THEREFORE, BAXTER DOES NOT HAVE REPORTING RESPONSIBILITY.