BD ECLIPSE¿ NEEDLE
Report
- Report Number
- 8041187-2023-00449
- Event Type
- Malfunction
- Date Received
- August 18, 2023
- Date of Event
- August 2, 2023
- Report Date
- November 27, 2023
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 30382903057642
- PMA / PMN Number
- K010188
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
BASED ON THE DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCH. CURRENT CONTROL THERE IS A VISUAL INSPECTION ON DAMAGED PACKAGE AT THE QA OUTGOING INSPECTION PER MQA-052/E AND VISUAL INSPECTION ON DAMAGED PACKAGE (HOLES/SLITS/TEAR) AT THE PACKAGING IN-PROCESS INSPECTION PER MFG-043/L. BASED ON THE RECEIVED PHOTOS AND AVAILABLE INFORMATION OF 1 UNIT BLISTER MISSING FROM A BOX. SHOWING THAT THE 1 OUT 5 UNIT IN A SHEET COULD BE DROP OFF FROM THE SECONDARY PACKAGING PROCESS BEFORE PACKAGE INTO SHIPPER CARTON BOX. ECLIPSE MANUFACTURING PROCESS WAS REVIEW FROM SECONDARY PACKAGING OPERATION. PROBABLE ROOT CAUSE FOR THE MISSING AND DAMAGED PRODUCT COULD BE OCCURRED AT THE STACK INSERT DRIVER LOADING OF 5PCS IN SHEET INTO THE CARTON BOX. THIS COULD BE DUE TO WHEN ECLIPSE NEEDLE 5PCS IN A SHEET IS NOT PLACED FLAT DURING INSERTION INTO CARTON. THUS, THE CORNER OF THE BLISTER WILL BE HIT AGAIN THE SIDE GUIDE RESULTING DAMAGED THE PACKAGE OR TEAR OFF MISSING (REFER TO ATTACHMENT C). ACTION HAD BEEN TAKEN TO MODIFY AND EXTEND THE BOTTOM GUIDE PLATE TO SUPPORT THE BLISTER TO ENSURE THE ¿FLATNESS¿ DURING INSERTION TO CARTON ON 27 SEP 2023 (REFER TO ATTACHMENT D).
H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 5 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF SHORT COUNT AND PACKAGED DAMAGED / DEFECTIVE / OTHER WERE CONFIRMED UPON INSPECTION OF THE SAMPLE PHOTOS. ANALYSIS OF THE SAMPLE PHOTOS SHOWED THAT ONE BLISTER WAS MISSING AT THE CORNER AND THE PACKAGING WAS DAMAGED ON ONE OF THE SAMPLES. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO OUR MANUFACTURING PROCESS DURING LOADING OF THE PRODUCTS INTO THE CARTON. AN ACTION PLAN HAS BEEN PROPOSED TO ADDRESS THIS ROOT CAUSE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.
IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE UNIT PACKAGE WAS TORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR THE 2 BOXES, THE QUANTITY IS ONLY 99PCS EACH. THERE IS A SHORTAGE OF 1 ITEM IN EACH BOX; THE OTHER BOX CONTAINS 1 DEFECTIVE (TEAR). SHORT - 2 BOXES (100EA) - LOT 3011955 . DAMAGE - 1 BOX (100EA) - LOT 3011955.
FOR THE 2 BOXES, THE QUANTITY IS ONLY (B)(4) EACH. THERE IS A SHORTAGE OF 1 ITEM IN EACH BOX; THE OTHER BOX CONTAINS 1 DEFECTIVE (TEAR). SHORT - 2 BOXES (100EA) - LOT 3011955. DAMAGE - 1 BOX (100EA) - LOT 3011955.
IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE UNIT PACKAGE WAS TORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR THE 2 BOXES, THE QUANTITY IS ONLY 99PCS EACH. THERE IS A SHORTAGE OF 1 ITEM IN EACH BOX; THE OTHER BOX CONTAINS 1 DEFECTIVE (TEAR). SHORT - 2 BOXES (100EA) - LOT 3011955. DAMAGE - 1 BOX (100EA) - LOT 3011955".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2167150 | BD ECLIPSE¿ NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 3011955 | 30382903057642 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |