BD SYRINGE PLASTIPAK 20ML S/SU
Report
- Report Number
- 3003916417-2025-00001
- Event Type
- Malfunction
- Date Received
- January 10, 2025
- Date of Event
- November 14, 2024
- Report Date
- March 16, 2025
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMF
- UDI-DI
- 07891463000408
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
(B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE SYRINGE HAS HOLES. TO AID IN THE INVESTIGATION, A SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. IT WAS POSSIBLE TO OBSERVE THE MOLDING CONDITION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990173, LOT 4170648. INSPECTIONS WERE CARRIED OUT ACCORDING TO PLAN, NO RECORD OF THIS DEFECT WAS OBSERVED, AND THERE WERE NO QUALITY OCCURRENCES RELATED TO THIS INCIDENT. MAINTENANCE RECORDS WERE REVIEWED, AND A POSSIBLE RELATED INCIDENT WAS OBSERVED. ACCORDING TO THE MAINTENANCE ORDER, THE ROOT CAUSE OF THIS CONDITION WAS DIRT IN THE CYLINDER INJECTION NOZZLES. ACTIONS WERE TAKEN INCLUDING POLISHING OF ALL THE CORES AND CAVITIES, REPLACING SOME CAVITIES, AND CLEANING OF THE INJECTION NOZZLES OF PARTS THAT SHOWED BUBBLES OR SIGNS OF HOLES. OPERATORS WILL BE INFORMED OF THE FAILURE. BASED ON THE REVIEW AND ANALYSIS OF THE SAMPLES RECEIVED, BD CONFIRMS THE INCIDENT IN QUESTION.
(B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THE SYRINGE HAS HOLES. TO AID IN THE INVESTIGATION, A SAMPLE, PHOTOS AND VIDEOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. IT WAS POSSIBLE TO OBSERVE THE MOLDING CONDITION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990173, LOT 4170648. INSPECTIONS WERE CARRIED OUT ACCORDING TO PLAN, NO RECORD OF THIS DEFECT WAS OBSERVED, AND THERE WERE NO QUALITY OCCURRENCES RELATED TO THIS INCIDENT. MAINTENANCE RECORDS WERE REVIEWED, AND A POSSIBLE RELATED INCIDENT WAS OBSERVED. ACCORDING TO THE MAINTENANCE ORDER, THE ROOT CAUSE OF THIS CONDITION WAS DIRT IN THE CYLINDER INJECTION NOZZLES. ACTIONS WERE TAKEN INCLUDING POLISHING OF ALL THE CORES AND CAVITIES, REPLACING SOME CAVITIES, AND CLEANING OF THE INJECTION NOZZLES OF PARTS THAT SHOWED BUBBLES OR SIGNS OF HOLES. OPERATORS WILL BE INFORMED OF THE FAILURE. BASED ON THE REVIEW AND ANALYSIS OF THE SAMPLE, PHOTOS AND VIDEOS RECEIVED, BD CONFIRMS THE INCIDENT IN QUESTION.
IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 20ML S/SU MOLDING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: OUR TECHNICAL TEAM HAS BEEN REPORTING THAT IN RECENT DAYS THE DISPOSABLE SYRINGE 20ML WITHOUT NEEDLE - REF. (B)(4) - LOT 4170648 IS SHOWING HOLES. PRODUCT: SYRINGE DESC.20ML S/AG S/THREAD PLASTIPAK UND (990173) BD. QUANTITY RETURNED BY CUSTOMER: (B)(4) UNITS. LOT: 4170648 ADDITIONAL INFO RECEIVED. DEC 19.2024 COULD YOU CONFIRM THE AMOUNT AFFECTED? UNFORTUNATELY, WHEN THE OCCURRENCE REACHED OUR SECTOR, SOME UNITS HAD ALREADY BEEN DISCARDED BY THE TEAM. COULD YOU CONFIRM THE DATE OF OCCURRENCE OF THE EVENT? THE FIRST CASE OCCURRED BEFORE (B)(6)2024. IS THERE ANY PATIENT INVOLVEMENT? NO PATIENT WAS AFFECTED, AS THE PREPARATION IS CARRIED OUT IN A DIFFERENT PLACE THAN THE APPLICATION. WAS THERE ANY HARM TO PATIENTS/HEALTH PROFESSIONALS? NO.
NO ADDITIONAL INFORMATION RECEIVED.
NO ADDITIONAL INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498836 | BD SYRINGE PLASTIPAK 20ML S/SU | PISTON SYRINGE | FMF | BECTON DICKINSON IND. CIRURGICAS LTDA | 4170648 | 07891463000408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |