WARMER DRAPE
Received Oct 19, 2015
Report 8043817-2015-00006 · MDR key 5159868
Device
Generic name
Warmer Drape
Manufacturer
Microtek Dominicana, S.aModel number
ORS-300NCatalog number
ORS-300N
Lot number
D142511
Product problems
- Hole In Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION WAS COMPLETED AT THE MANUFACTURING SITE IN THE (B)(4). BASED ON THE DHR RECORD WAS REVIEWED AND IT WAS SEEN THAT DRAPE WAS MANUFACTURED TO THE SPECIFICATION AT TIME OF MANUFACTURE. NO DEFECTS WERE REPORTED DURING PROCESSING, PACKAGING OR FINAL INSPECTION. THE INVESTIGATION REVEALED THAT THIS PROBLEM WAS NOT DUE TO AN ASSEMBLY, MATERIAL, OR PROCESS ISSUES. NO DEFECTIVE PRODUCT HAS BEEN RETURNED TO MANUFACTURER FOR EVALUATION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
CARDINAL RECEIVED A CUSTOMER COMPLAINT REGARDING THE WARMER DRAPE CONTAINED IN THE CARDINAL CRANIOTOMY PACK. THE WARMER DRAPES IN THREE OF THE KITS HAD HOLES. ADDITIONAL POST SURGICAL CARE WAS WARRANTED FOR ONE PATIENT DUE TO CONCERNS REGARDING LOSS OF STERILE FIELD; THE PATIENT WAS NOT INJURED. THE DEFECTIVE PRODUCT WAS NOT AVAILABLE FOR RETURN.