ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jul 30, 2012 · Event occurred Jun 7, 2012
Report 2210968-2012-03337 · MDR key 2673594
Device
Generic name
Suture, 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). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
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IT WAS REPORTED THAT WHILE SEARCHING INVENTORY FOR OUTDATED PRODUCT ON (B)(6) 2012, THE ACCOUNT NOTED THAT THE TYVEK CO-POLYMER OVERWRAP WAS OPENING AND FALLING APART.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). 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 TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2012-03336.
Remedial action
- Other