BD NEEDLE PRECISIONGLIDE 18X1-1/2IN
Report
- Report Number
- 3003916417-2025-00290
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- October 21, 2025
- Report Date
- January 15, 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
- 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.
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: PHOTO 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.
(B)(4) FOLLOW UP REPORT FOR CORRECTION. 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: IT WAS REPORTED THAT THE ITEM: DESCRIPTION PRECISION GLIDE RS 40X1,20MM BOX 100UN BD NEEDLE 300017. LOT: 5212927, REASON: THE DESCRIPTION 40X12 NEEDLE WAS SENT, BUT WE FOUND THE 30X08 NEEDLE INSIDE THE BOX OF 40X12 NEEDLE ON SOME BOXES. ADDITIONAL INFORMATION RECEIVED ON 25 NOV 2025: AMOUNT AFFECTED: (B)(4) UNITS 30X08 NEEDLES. ANVISA NOTIFICATION NUMBER: WE HAVE NOT MADE ANY NOTIFICATION TO ANVISA.
NO ADDITIONAL INFORMAITON PROVIDED.
FIELD ACTION NOTIFICATION: MDS-26-06011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510117 | 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 |