ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Aug 20, 2012
Report 2210968-2012-04193 · MDR key 2705393
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
PXX52
Lot number
EEZ521
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS NOTED THAT THE NEEDLE WAS PROTRUDING THROUGH THE PACKAGE AND PACKAGING INTEGRITY MAY HAVE BEEN COMPROMISED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Additional Manufacturer Narrative
(B)(6). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative
(B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE OVERWRAP PACKAGE AND IT WAS OBSERVED THAT THERE WERE 4 HOLES ON THE COPOLYMER.THE MSDA FOLDER WAS EXAMINED AND IT WAS OBSERVED THAT THERE WERE 2 HOLES ON THE FOLDER AND 3 HOLES INSIDE OF THE FOLDER. 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): 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.
Remedial action
- Other