ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jul 3, 2012 · Event occurred Jun 7, 2012
Report 2210968-2012-02551 · MDR key 2638616
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
Description of Event or Problem
IT WAS REPORTED THAT WHILE SEARCHING INVENTORY FOR OUTDATED PRODUCT ON (B)(6) 2012, THE ACCOUNT NOTED THAT THE TYVEK CO-POLYMER OVERWRAP WAS OPENING AND FALLING APART.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.
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). PACKAGING IS OPENING AND FALLING APART. 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.
Remedial action
- Other