BD NEEDLE PRECISIONGLIDE 21X1IN
Report
- Report Number
- 3003916417-2026-00022
- Event Type
- Malfunction
- Date Received
- January 16, 2026
- Date of Event
- May 5, 2025
- Report Date
- April 29, 2026
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMI
- UDI-DI
- 30000078909794
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PACKAGE DAMAGED / DEFECTIVE / OTHER A DETAILED ANALYSIS OF THE LOT HISTORY (DHR) WAS PERFORMED, ALONG WITH A REVIEW OF ALL QUALITY NOTIFICATIONS, PRODUCTION RECORDS, AND MAINTENANCE RECORDS ASSOCIATED WITH THE LOT IN QUESTION. NO PRIOR RECORDS OR DEVIATIONS RELATED TO THE REPORTED DEFECT WERE IDENTIFIED. FOR THE DEFECT CLASSIFIED AS PACKAGE DAMAGED / DEFECTIVE / OTHER, THE COMPLAINT WAS NOT CONFIRMED. THE RECEIVED SAMPLE WAS SUBJECTED TO THE CARBON TEST, IN ACCORDANCE WITH THE APPLICABLE PROCEDURE, AND NO PERFORATION OR LOSS OF PACKAGE INTEGRITY WAS IDENTIFIED, AS EVIDENCED BY THE ATTACHED TEST REPORT. TEAR IN THE PACKAGING A METICULOUS ANALYSIS OF THE LOT HISTORY (DHR) WAS CONDUCTED, AND ALL PRODUCTION, MAINTENANCE, AND QUALITY NOTIFICATION RECORDS ASSOCIATED WITH THIS LOT WERE REVIEWED. NO DEVIATIONS OR NONCONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE RECEIVED SAMPLE WAS EVALUATED, AND THE TEAR OBSERVED IN THE PACKAGING IS CONSISTENT WITH DAMAGE CAUSED DURING THE BLISTER SEPARATION PROCESS. WHEN THIS PROCEDURE IS PERFORMED INCORRECTLY, IT MAY RESULT IN MECHANICAL TEARING OF THE PACKAGING, WHICH IS NOT RELATED TO THE MANUFACTURING OR SEALING PROCESS. BASED ON THIS ANALYSIS, BD DOES NOT CONFIRM THE COMPLAINT. CONCLUSION BASED ON THE AVAILABLE INFORMATION AND THE ANALYSES PERFORMED, THE VALIDITY OF THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURING PROCESS IS VALIDATED ACCORDING TO PREDEFINED ACCEPTANCE CRITERIA AND COMPLIES WITH APPLICABLE QUALITY REQUIREMENTS. THE REPORTED INCIDENT WILL BE CONTINUOUSLY MONITORED FOR TREND EVALUATION PURPOSES. AS THIS OCCURRENCE DOES NOT EXCEED THE ACCEPTABLE QUALITY LIMIT (AQL) OF THE LOT, NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS ARE PROPOSED AT THIS TIME.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO ADDITIONAL INFORMATION PROVIDED.
IT WAS REPORTED THAT BD EVA-AI3-SM3 NEEDLE PRECISIONGLIDE 21X1IN PACKAGE WAS DAMGED. BATCH: 5031737. QUANTITY: (B)(4). REASON: 5 DIRTY IN THE PACKAGING AND INSIDE THE NEEDLE, 2 EXTENSIONS IN THE PROTECTIVE COVER PIERCING THE PACKAGING, 1 DEFORMATION IN THE BEVEL, 1 BROKEN, 1 TEAR IN THE PACKAGING. BATCH: 4173465. QUANTITY: (B)(4). REASON: 2 INTERNAL DIRT. BATCH: 4204356. QUANTITY: (B)(4). REASON: 3 FOREIGN BODIES INSIDE THE NEEDLE, 2 DIRT INSIDE THE NEEDLE, 2 BROKEN CANNONS, 1 TEAR IN THE PACKAGING. ADDITIONAL INFORMATION RECEIVED ON 02 JAN 2026. BASED ON THE ANALYSIS OF THE PHOTOS YOU PROVIDED, WE IDENTIFIED THE NEW BATCH NUMBER 4120787 WITH THREE ASSOCIATED PHOTOS. COULD YOU CONFIRM FROM WHICH DISTRIBUTOR THIS BATCH WAS PURCHASED? 4120787 - CM HOSPITALAR MAFRA NF: 1160235 - (B)(4) UNITS DIRTY. IT WAS A BATCH WITHOUT INCLUDING. WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? NO, ONLY THE COMPANY. COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442706 | BD NEEDLE PRECISIONGLIDE 21X1IN | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON IND. CIRURGICAS LTDA | 4204356 | 30000078909794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |