SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC
Received Aug 12, 2020 · Event occurred Jul 23, 2020
Report 1920898-2020-01042 · MDR key 10398354
Device
Product problems
- Fungus in Device Environment
- Device Contamination with Chemical or Other Material
- Fungus in Device Environment
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC HAD FOREIGN MATTER AND MOLD ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAIN AND MOLD ON THE SWAB.
Additional Manufacturer Narrative
H.6. INVESTIGATION: CUSTOMER RETURNED (2) BD ALCOHOL SWABS (1 OPEN, 1 SEALED) FROM LOT # 0023978. CUSTOMER STATES THAT THERE IS A STAIN AND MOLD ON THE SWAB. THE OPEN SWAB WAS EXAMINED AND EXHIBITED MATERIAL ON THE SWAB PAD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY A COMBINATION OF SWAB PAD MATERIAL, CELLULOSE AND LIGNIN, AND GREASE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0023978. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROCESS: THE ALCOHOL SWAB IS PRODUCED BY SLITTING A BULK ROLL OF THE PAD MATERIAL INTO 1.125¿ WIDTHS AND SEPARATING THOSE STRIPS TO THE PROPER CENTERS FOR PACKAGING. PRIOR TO FINAL SEALING INTO THE POUCH, THE STRIPS ARE CUT TO LENGTH AND SATURATED WITH ALCOHOL. ONCE SATURATED AND CUT, THE SWABS ARE PROMPTLY SEALED INTO THE POUCH. INVESTIGATION: THE DHR, L2L DISPATCHES, LOGBOOKS AND QUALITY NOTIFICATIONS WERE ALL REVIEWED. NO EVIDENCE OF THE NONCONFORMANCES RESULTED FROM THE HOLDREGE OPERATION HOWEVER TWO ZV¿S (VENDOR NOTIFICATIONS) WERE CREATED FOR FM ON THE FIBERTEX SWAB PAD MATERIAL THAT ¿LOOKED LIKE RUST SPOTS¿ IN NOVEMBER AND DECEMBER 2019. THE AFFECTED PAD ROLLS WERE REMOVED AND RETURNED TO THE VENDOR. THE REMAINING PAD BATCH INVENTORY REMAINED AT HOLDREGE AS NO OTHER ¿RUST SPOTS¿ WERE NOTED AT THAT TIME. THE VENDOR INITIATED AN 8D TO IDENTIFY THE ROOT CAUSE. ROOT CAUSE: THE VENDORS DOCUMENTED RESPONSE FROM THE 8D INVESTIGATION, ¿(ESCAPE) AGED CLUMPS OF VISCOSE FIBER, WHICH HAD ORIGINATED FROM OUR NEEDLE LOOMS. CLUMPS THIS CONCENTRATED TYPICALLY OCCUR AFTER A CLEANING SEQUENCE, AND SOMETHING THIS LARGE DOES (SHOULD) NOT GO UNNOTICED¿. VENDOR PRODUCTION REPORTS FOR THE BATCH PAD MATERIAL DO NOT INDICATE ISSUES WITH CONTAMINATION BUT INDICATED A LOOM CLEANING SEQUENCE TOOK PLACE. CORRECTIVE ACTION: ROUTINE AND RAMPED UP CLEANINGS, WHEN RUNNING LONG SEGMENTS OF VISCOSE, WILL PREVENT THIS EXPOSURE. PERMANENT ACTION: REINVESTIGATING INVESTMENT INITIATIVE TO INSTALL A VISION INSPECTION SYSTEM.
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC HAD FOREIGN MATTER AND MOLD ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAIN AND MOLD ON THE SWAB.