PEANUT SPONGE
Received May 19, 2017 · Event occurred Mar 30, 2017
Report 3010452421-2017-00003 · MDR key 6579119
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Suzhou Avon Textile Co. Ltd.Model number
30-106Lot number
40417599
Product problems
- Material Separation
- Material Integrity Problem
- Material Separation
- Material Integrity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ROOT CAUSE: BASED ON THE COMPLAINT DESCRIPTION, THIS HAS BEEN DETERMINED TO BE A VENDOR ISSUE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPONGE MANUFACTURER, A-PLUS INTERNATIONAL. IN ITS RESPONSE, A-PLUS STATED THE COMPLAINT INFORMATION WAS FORWARDED TO THE FACTORY TO INCREASE THEIR AWARENESS FOR SIMILAR INCIDENTS. TO ENSURE THE FACTORY'S INSPECTION PROCEDURES ARE EFFECTIVE, THEY HAVE INSTRUCTED THEIR INSPECTORS TO PAY SPECIAL ATTENTION WHEN PERFORMING THE INSPECTION OF IN-PROCESS AND FINISHED PRODUCT. THEY WILL CONTINUE TO MONITOR THIS COMPLAINT AND IMPLEMENT ADDITIONAL CORRECTIVE/PREVENTIVE ACTIONS AS NECESSARY. AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A PEANUT SPONGE (PART NUMBER 30-106) CAME APART DURING A SURGICAL PROCEDURE. THE SAMPLE WAS UNAVAILABLE FOR RETURN. PROCESS RECORDS WERE REVIEWED AND NO ISSUES RELATED TO THE SPONGE WERE FOUND DURING WORK ORDER PROCESSING. QUALITY CONTROL INSPECTION OF THE REFERENCED LOT NUMBER DID NOT SHOW ANY ISSUES. A TOTAL 315 PACKS OF THE 32,100 PACKS PRODUCED DURING THE WORK ORDER WERE CHECKED. A WORK IN PROCESS EVALUATION ALSO WAS PERFORMED AND DID NOT SHOW ANY ISSUES. THE RAW MATERIAL SPONGE IS SUPPLIED TO DEROYAL BY A-PLUS INTERNATIONAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED MAY 3 TO A-PLUS AND A RESPONSE WAS RECEIVED. A TOTAL OF (B)(4) PACKS FOR THE PART REFERENCED IN THE COMPLAINT WERE SOLD FROM (B)(6) 2015, TO (B)(6) 2017. A TOTAL OF 206 PACKS HAVE BEEN REPORTED WITH ISSUES DURING THE SAME TIME PERIOD. THE COMPLAINT-TO-SALES RATIO IS 0.01%. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN.
Description of Event or Problem
THE PRODUCT CAME APART DURING SURGERY. THE NURSE SAW THAT IT LEFT A SMALL PIECE OF MATERIAL, BUT THE STAFF REMOVED IT.
Additional Manufacturer Narrative
AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A PEANUT SPONGE (PART NUMBER 30-106) CAME APART DURING A SURGICAL PROCEDURE. THE SAMPLE WAS UNAVAILABLE FOR RETURN. THE RAW MATERIAL SPONGE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED MAY 3 TO (B)(4). A RESPONSE WAS RECEIVED MAY 9. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
THE PRODUCT CAME APART DURING SURGERY. THE NURSE SAW THAT IT LEFT A SMALL PIECE OF MATERIAL, BUT THE STAFF REMOVED IT.
Remedial action
- Replace