NEEDLE 18GA 1IN BLUNT FILL SLA
Report
- Report Number
- 3003916417-2021-00323
- Event Type
- Malfunction
- Date Received
- October 18, 2021
- Date of Event
- September 20, 2021
- Report Date
- December 16, 2021
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-16 . H6: INVESTIGATION SUMMARY SAMPLE AND PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION IT WAS POSSIBLE TO OBSERVE THE INCIDENT OF A MIXED PRODUCT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROUTINE ANALYZES DURING PRODUCTION WERE PERFORMED AND RECORDED IN THE LINE CONTROL PLAN. NO INCIDENT WAS OBSERVED. NO QUALITY NOTIFICATION WERE OBSERVED THAT WERE POTENTIALLY RELATED TO THE INCIDENT. NO MAINTENANCE WAS OBSERVED THAT WAS POTENTIALLY RELATED TO THE INCIDENT. THE PROBABLE ROOT CAUSE OF THE INCIDENT IS THE FAILURE TO CLEAN THE EQUIPMENT ON BATCH CHANGE. NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTION IS NECESSARY AT THIS TIME.
H.6. INVESTIGATION: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION IT WAS POSSIBLE TO OBSERVE THE INCIDENT OF A MIXED PRODUCT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROUTINE ANALYZES DURING PRODUCTION WERE PERFORMED AND RECORDED IN THE LINE CONTROL PLAN. NO INCIDENT WAS OBSERVED. NO QUALITY NOTIFICATION WERE OBSERVED THAT WERE POTENTIALLY RELATED TO THE INCIDENT. NO MAINTENANCE WAS OBSERVED THAT WAS POTENTIALLY RELATED TO THE INCIDENT. THE PROBABLE ROOT CAUSE OF THE INCIDENT IS THE FAILURE TO CLEAN THE EQUIPMENT ON BATCH CHANGE. H3 OTHER TEXT : SEE H.10.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT NEEDLE 18GA 1IN BLUNT FILL SLA CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING PRINTING ERROR. CUSTOMER SENT TO US THE ADDITIONAL INFORMATION. ¿ WHAT WOULD BE THE PRINTING ERROR ON THE PACKAGE? (DETAIL) THE PACKAGING REFERS TO A NEEDLE OTHER THAN THE ONE INSIDE. ¿ WHICH PACKAGE HAS THE DEVIATION (BLISTER, CARTON OR SHIPPING BOX)? IT IS THE SECONDARY PACKAGING (BLISTER). ¿ COULD YOU FORWARD PHOTOS OF THE BOX LABEL? IT CAN BE FROM THE SHIPPING BOX (TERTIARY PACKAGING) OR FROM THE CARTON (PRINTED INFORMATION REGARDING THE LOT AND BOX NUMBER - SECONDARY PACKAGING) AS FOR THE PHOTOS ON THE BOX LABEL, IT IS NOT POSSIBLE TO SEND, AS WE DISCARD THEM AS SOON AS WE EXPOSE THE MATERIALS ON THE MATERIAL SHELVES. CUSTOMER SENT TO US THE FORM WITH THE DESCRIPTION. DURING THE PERIOD OF SEPARATION OF MATERIALS AND MEDICINES FROM THE PATIENT, THE PHARMACY ASSISTANT LOCATED THE NEEDLE, AS SHE WANTED TO DISPENSE WITH THE 25X12MM NEEDLE, HOWEVER, IT WAS OBSERVED THAT IT WAS ANOTHER TYPE OF 07X25MM NEEDLE IN THE WRONG PACKAGING.
IT WAS REPORTED THAT NEEDLE 18GA 1IN BLUNT FILL SLA CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING PRINTING ERROR. _____ CUSTOMER SENT TO US THE ADDITIONAL INFORMATION. WHAT WOULD BE THE PRINTING ERROR ON THE PACKAGE? (DETAIL) THE PACKAGING REFERS TO A NEEDLE OTHER THAN THE ONE INSIDE. WHICH PACKAGE HAS THE DEVIATION (BLISTER, CARTON OR SHIPPING BOX)? IT IS THE SECONDARY PACKAGING (BLISTER). COULD YOU FORWARD PHOTOS OF THE BOX LABEL? IT CAN BE FROM THE SHIPPING BOX (TERTIARY PACKAGING) OR FROM THE CARTON (PRINTED INFORMATION REGARDING THE LOT AND BOX NUMBER - SECONDARY PACKAGING) AS FOR THE PHOTOS ON THE BOX LABEL, IT IS NOT POSSIBLE TO SEND, AS WE DISCARD THEM AS SOON AS WE EXPOSE THE MATERIALS ON THE MATERIAL SHELVES. CUSTOMER SENT TO US THE FORM WITH THE DESCRIPTION. DURING THE PERIOD OF SEPARATION OF MATERIALS AND MEDICINES FROM THE PATIENT, THE PHARMACY ASSISTANT LOCATED THE NEEDLE, AS SHE WANTED TO DISPENSE WITH THE 25X12MM NEEDLE, HOWEVER, IT WAS OBSERVED THAT IT WAS ANOTHER TYPE OF 07X25MM NEEDLE IN THE WRONG PACKAGING.
IT WAS REPORTED THAT NEEDLE 18GA 1IN BLUNT FILL SLA CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING PRINTING ERROR. CUSTOMER SENT TO US THE ADDITIONAL INFORMATION. WHAT WOULD BE THE PRINTING ERROR ON THE PACKAGE? (DETAIL) THE PACKAGING REFERS TO A NEEDLE OTHER THAN THE ONE INSIDE. WHICH PACKAGE HAS THE DEVIATION (BLISTER, CARTON OR SHIPPING BOX)? IT IS THE SECONDARY PACKAGING (BLISTER). COULD YOU FORWARD PHOTOS OF THE BOX LABEL? IT CAN BE FROM THE SHIPPING BOX (TERTIARY PACKAGING) OR FROM THE CARTON (PRINTED INFORMATION REGARDING THE LOT AND BOX NUMBER - SECONDARY PACKAGING). AS FOR THE PHOTOS ON THE BOX LABEL, IT IS NOT POSSIBLE TO SEND, AS WE DISCARD THEM AS SOON AS WE EXPOSE THE MATERIALS ON THE MATERIAL SHELVES. CUSTOMER SENT TO US THE FORM WITH THE DESCRIPTION. DURING THE PERIOD OF SEPARATION OF MATERIALS AND MEDICINES FROM THE PATIENT, THE PHARMACY ASSISTANT LOCATED THE NEEDLE, AS SHE WANTED TO DISPENSE WITH THE 25X12MM NEEDLE, HOWEVER, IT WAS OBSERVED THAT IT WAS ANOTHER TYPE OF 07X25MM NEEDLE IN THE WRONG PACKAGING.
IT WAS REPORTED THAT NEEDLE 18GA 1IN BLUNT FILL SLA CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING PRINTING ERROR. CUSTOMER SENT TO US THE ADDITIONAL INFORMATION. ¿ WHAT WOULD BE THE PRINTING ERROR ON THE PACKAGE? (DETAIL) THE PACKAGING REFERS TO A NEEDLE OTHER THAN THE ONE INSIDE. ¿ WHICH PACKAGE HAS THE DEVIATION (BLISTER, CARTON OR SHIPPING BOX)? IT IS THE SECONDARY PACKAGING (BLISTER). ¿ COULD YOU FORWARD PHOTOS OF THE BOX LABEL? IT CAN BE FROM THE SHIPPING BOX (TERTIARY PACKAGING) OR FROM THE CARTON (PRINTED INFORMATION REGARDING THE LOT AND BOX NUMBER - SECONDARY PACKAGING) AS FOR THE PHOTOS ON THE BOX LABEL, IT IS NOT POSSIBLE TO SEND, AS WE DISCARD THEM AS SOON AS WE EXPOSE THE MATERIALS ON THE MATERIAL SHELVES. CUSTOMER SENT TO US THE FORM WITH THE DESCRIPTION. DURING THE PERIOD OF SEPARATION OF MATERIALS AND MEDICINES FROM THE PATIENT, THE PHARMACY ASSISTANT LOCATED THE NEEDLE, AS SHE WANTED TO DISPENSE WITH THE 25X12MM NEEDLE, HOWEVER, IT WAS OBSERVED THAT IT WAS ANOTHER TYPE OF 07X25MM NEEDLE IN THE WRONG PACKAGING.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FAX#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT NEEDLE 18GA 1IN BLUNT FILL SLA HAD A PRINTING ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING PRINTING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1543241 | NEEDLE 18GA 1IN BLUNT FILL SLA | NEEDLE | FMI | BECTON DICKINSON IND. CIRURGICAS LTDA | 1119328 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |