CUSTOMED STERILE CONVENIENCE PACKS SURGICAL
Received Sep 5, 2014 · Event occurred Aug 29, 2014
Report 2648727-2014-00001 · MDR key 4146661
Device
Product problems
- Air Leak
- Device Disinfection Or Sterilization Issue
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
BUBBLE EMISSION LEAK TEST FAIL COMPROMISING THE STERILITY OF PRODUCTS SHIPPED BY AIR PRODUCED BY CUSTOMED INC. AND DISTRIBUTED BY PR HOSPITAL INC. AND CUSTOMED USA INC. THE PRODUCT PACKAGE INTEGRITY FOR STERILITY IS CONSIDERED A PATIENT HEALTH HAZARD. RESULTS OF THE BUBBLE EMISSION LEAK TEST GLP REPORT ARE ATTACHED TO THIS DOCUMENT. THIS PRODUCT TEST WAS PART OF THE RISK ASSESSMENT OF CAPA (B)(4) OPENED AS A RESPONSE TO THE FDA 483 OBSERVATIONS FROM (B)(6) 2014. CUSTOMED PRODUCT CATALOGS THAT ARE SUBJECTED TO INVESTIGATION DUE TO THIS EVENT ARE LISTED.
Additional Manufacturer Narrative
AN EVALUATION PERFORMED THROUGH A RISK ASSESSMENT IDENTIFIED AN ADVERSE TREND REGARDING PACKAGING AND SHIPPING CONTAINERS IN 2014. AS A CONSEQUENCE IT WAS CONDITIONED THE RELEASE OF THE PRODUCTS TO THE FOLLOWING PREVENTIVE REQUIREMENTS: BATCH RECORD IN-PROCESS REQUIREMENTS. VISUAL INSPECTION POST-STERILIZATION WITH ZERO DEFECTS 100%. ACCEPTABLE VISUAL INSPECTION AFTER SIMULATED SHIPPING CONDITIONS. ACCEPTABLE INTERNAL PRESSURIZATION RESISTANCE TEST (POST STERILIZATION) OF UNRESTRAINED PACKAGES (BURST TEST) OF PRODUCTS. ACCEPTABLE BUBBLE EMISSION TEST TO PRODUCTS (EXTERNAL LABORATORY). SHIPPING REPORT REGARDING MATERIAL RELEASED WILL BE CONFIRMED BY QA PERSONNEL BEFORE TRANSFER OF PRODUCTS TO DISTRIBUTION CENTERS. MEDWATCH FORM FDA 3500A WAS SUBMITTED BECAUSE THE BUBBLE EMISSION LEAK TEST FAIL COMPROMISING THE STERILITY OF CONVENIENCE PACKS FOR SURGICAL USE PRODUCED AND DISTRIBUTED BY CUSTOMED INC. (B)(6) HOSPITAL, INC. AND CUSTOMED USA INC.