ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jul 3, 2012 · Event occurred Jun 7, 2012
Report 2210968-2012-02552 · MDR key 2638602
Device
Generic name
Suture, Non Absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
X871H
Lot number
BCP315
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE EVALUATION FOUND THE PAPER COVER WAS YELLOWISH INSTEAD OF ORANGE AND IT WAS FALLING APART.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWELVE MEDWATCHES BEING SUBMITTED AS TWELVE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2012-02541 THROUGH 2210968-2012-02552.
Description of Event or Problem
IT WAS REPORTED THAT WHILE SEARCHING INVENTORY FOR OUTDATED PRODUCT ON (B)(4) 2012, THE ACCOUNT NOTED THAT THE TYVEK CO-POLYMER OVERWRAP WAS OPENING AND FALLING APART. THE PRODUCT WAS STORED IN A PYXIS AUTOMATED DISPENSING MACHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Remedial action
- Other