ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received May 7, 2013 · Event occurred Apr 12, 2013
Report 2210968-2013-05133 · MDR key 3096319
Device
Generic name
Suture, Non Absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
EH7687H
Lot number
EME996
Product problems
- Break
Patient
Not reported
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBCLAVIAN CENTRAL VENOUS CATHETER INSERTION ON (B)(6) 2013 AND SUTURE WAS USED. WHILE SUTURING THE SKIN, THE NEEDLE BROKE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO LOCATE THE NEEDLE UNDER SCOPY. A SURGICAL INCISION WAS MADE TO REMOVE THE NEEDLE. A LIKE DEVICE WAS USED TO STITCH THE CATHETER IN PLACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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
(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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Remedial action
- Other