ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Oct 22, 2012 · Event occurred Sep 28, 2012
Report 2210968-2012-06701 · MDR key 2799380
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
NI
Lot number
NI
Product problems
- Material Frayed
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPAIR ON (B)(6) 2012 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PLEDGET WAS FRAYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND EXAMINED FOR FRAYING. NO ANOMALIES OBSERVED WITH THE PLEDGETS. NO FRAYING OBSERVED. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING POSSIBLE BATCH NUMBER WAS REPORTED: SXP82, LOT DP6530, MFG DATE: 12/01/2011, EXP DATE: 07/31/2016. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Additional Manufacturer Narrative
(B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative
CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS MICROSCOPICALLY EVALUATED. THE PLEDGET ON THE UNDISPENSED SUTURE IS A SOFT PLEDGET, WHICH HAS A FUZZIER APPEARANCE COMPARED TO HARD PLEDGETS. IT MAY HAVE APPEARED TOO FUZZY TO THE END-USER, BUT IT IS CONSISTENT IN APPEARANCE WITH A SOFT PLEDGET.
Remedial action
- Other