BD NEEDLE PRECISIONGLIDE 18X1-1/2IN
Report
- Report Number
- 3003916417-2025-00291
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- September 22, 2025
- Report Date
- January 21, 2026
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMI
- PMA / PMN Number
- NA
- Removal / Correction Number
- MDS-26-06011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
(B)(4) FOLLOW UP REPORT FOR CORRECTION. FIELD ACTION NOTIFICATION: MDS-26-06011.
D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
SUMMARY OF ASSESSMENT AND ACTIONS TAKEN: A COMPREHENSIVE REVIEW OF THE BATCH HISTORY (DHR) WAS CONDUCTED, INCLUDING MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS. NO DEVIATIONS RELATED TO THE INCIDENT WERE IDENTIFIED. ANALYSIS OF SAMPLES AND EVIDENCE. SAMPLES AND IMAGES OF THE REPORTED INCIDENT WERE RECEIVED AND ANALYZED FOR INITIAL ASSESSMENT. BD CONFIRMS THE INCIDENT. EVALUATION OF PAPER RETENTION SAMPLES (INSPECTIONS EVERY 2 HOURS): INSPECTED BOXES: 01, 92, 179, 274, 378, 482, 593, 701, 810, 919, 1032, 1144, 1255, 1372, 1472, 1588, 1675, 1782, 1898, 2004, AND 2120. EVALUATION OF FINISHED LOT REFERENCE SAMPLES (FINISHED GOODS RETENTION): INSPECTED BOXES: 10, 726, 1085, 1443, 1801, 1259. ROOT CAUSE: DEFECT 1: MIXED PAPER BATCH. DEFECT 2: BARCODE READING SENSOR FAILURE. CONTAINMENT ACTIONS. BARCODE SENSOR VERIFICATION: THE SENSOR READS THE CODE; HOWEVER, THE SYSTEM DOES NOT IDENTIFY THAT THE BARCODE IS INCORRECT. ACTION COMPLETED. SCOPE OF SEEBS: IT WAS FOUND THAT SEEBS 03, 07, 08, 11, 12, AND 15 EXHIBIT THE SAME BEHAVIOR. INVESTIGATION STATUS: THE COMPLETE INVESTIGATION IS DOCUMENTED AND ATTACHED IN THE FILE INVESTIGATION OVERVIEW.
FIELD ACTION NOTIFICATION: MDS-26-06011.
IT WAS REPORTED THAT THE BD NEEDLE PRECISIONGLIDE 18X1-1/2IN LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT REGARDING THE DISPOSABLE NEEDLE 40 X 1.20, REPORTING THAT UPON OPENING THE BOX, THE MEASUREMENTS SHOWN ON THE PACKAGING LABEL DIFFER FROM THE CORRECT PRODUCT MEASUREMENTS, AS SHOWN IN THE ATTACHED IMAGES. THIS COULD POSE A RISK WHEN USING THE NEEDLE ON PATIENTS, GIVEN THAT THE 40 X 1.20 DISPOSABLE NEEDLE IS USED FOR ASPIRATION, WHILE THE 30 X 0.80 DISPOSABLE NEEDLE SHOWN ON THE LABEL IS USED FOR INTRAMUSCULAR ADMINISTRATION IN PATIENTS. THE FOLLOWING IS THE PRODUCT INFORMATION: DISPOSABLE NEEDLE 40 X 1.20 BATCH: 5212327 EXPIRATION DATE: 07/2030 NF: (B)(4) QUANTITY: (B)(4) UNITS SAMPLES AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 25, 2025 EMAIL FOLLOW UP: COULD YOU PLEASE PROVIDE THE DATE ON WHICH THE EVENT OCCURRED IN DD/MM/YYYY FORMAT? - DATE OF OCCURRENCE: (B)(6) 2025. COULD YOU PROVIDE THE NUMBER OF QUANTITIES AFFECTED BY THE REPORTED EVENT? - QUANTITY: (B)(4) UNITS. WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? - NOT YET. COULD YOU PLEASE CONFIRM WHETHER THE 30X0.80 DISPOSABLE NEEDLE IS EXPERIENCING THE SAME PROBLEM PREVIOUSLY REPORTED FOR THE 40X1.20 DISPOSABLE NEEDLE? - I CHECKED THE PRODUCTS IN STOCK AND SO FAR, NO NON-CONFORMITY HAS BEEN FOUND IN THE 30 X 0.80 DISPOSABLE NEEDLES. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 21, 2025 EMAIL FOLLOW UP: COULD YOU CONFIRM WHETHER THE INCIDENT WAS REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? - YES, THE EVENT WAS REPORTED TO ANVISA. NOTIFICATION NO. (B)(4).
NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2186793 | BD NEEDLE PRECISIONGLIDE 18X1-1/2IN | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON IND. CIRURGICAS LTDA | 5212927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |