3003916417-2018-00154
Report
- Report Number
- 3003916417-2018-00154
- Event Type
- Malfunction
- Date Received
- June 28, 2018
- Date of Event
- June 4, 2018
- Report Date
- July 27, 2018
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: DHR REVIEW: LOT 8046637 WAS MANUFACTURED BETWEEN FEBRUARY 23 TO 26, 2018 AND LOT 8030782 WAS MANUFACTURED BETWEEN FEBRUARY 22 AND 26, 2018. THE MATERIAL WAS MANUALLY PALLETIZED IN LOOPING AND STERILIZATION OF LOT 8046637 OCCURRED ON 02/27 AT 07:51 AM. FOR LOT 8030782 OCCURRED THE PREVIOUS DAY IN CASE (B)(6) 2018 AT 08:32. THE FACT THAT THESE MATERIALS WERE STERILIZED IN DIFFERENT CYCLES RESPECTIVELY 45800 AND 45794 INDICATING THAT THE PREPARATION OF THE LOAD WITH THE BIOLOGICAL INDICATORS OCCURRED AT DIFFERENT TIMES AND DURING THAT OPERATORS INSPECT THE LOAD AT THE END OF THE PREPARATION AND MAKE IT DIFFICULT TO MIX DURING PALLETIZING IN THE SORTER. QN/ MAINTENANCE REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) RECORDS AND THE PRESENT MAINTENANCE RECORDS DO NOT ALLOW TO CONFIRM DEFECT IN QUESTION AS THE TOTAL QUANTITIES WERE GENERATED ACCORDING TO LP AND AS MENTIONED ABOVE THE MATERIALS WERE PALLETIZED AND STERILIZED AT DIFFERENT TIMES. PHOTO SAMPLES WERE SENT BY THE CUSTOMER FOR ANALYSIS AND IT WAS NOT POSSIBLE CONFIRM THE DEFECT. IT WAS NOT POSSIBLE TO CONFIRM THE FACTORY PRODUCT MIX DEFECT IN VIEW OF THE INVESTIGATION DESCRIPTIONS. ANOTHER FACTOR EVALUATED IS THAT IN THE NUMBER OF THE CONSIGNMENT 6014568405, IT WAS POSSIBLE TO DETECT ONLY LOT 8046637 WITH QUANTITY DELIVERED OF 70 THOUSAND UNITS AND THE TOTAL VOLUME PRODUCED OF THIS LOT WAS 2,320,000 UNITS WHICH INDICATES THAT THERE WAS FRACTIONATION OF THE MATERIAL FOR SALE AND SUCH ACTIVITY IS NOT PART OF THE BD CURITIBA SCOPE. THE ROOT CAUSE FOR THE DEFECT IS RELATED TO FAILURE OF THE MATERIAL SCREENING PROCESS BY THE DHL CARRIER UPON RECEIPT OF THE MATERIAL. CAPA NOT REQUIRED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT BD PRECISIONGLIDE® SYRINGE NEEDLES CAME IN A BOX WITH MIXED PRODUCTS. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD PRECISIONGLIDE® SYRINGE NEEDLES CAME IN A BOX WITH MIXED PRODUCTS. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |