BD BBL¿ VOGES-PROSKAUER A REAGENT DROPPERS
Received Apr 1, 2026 · Event occurred Mar 19, 2026
Report 1119779-2026-00594 · MDR key 24754189
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
261192
Lot number
B01H316M
Product problems
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THIS MEMO SUMMARIZES THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) FOR PRODUCT 261192 (DROPPER VOGES-PROSKAUER A), BATCH NUMBER B01H316M. IT WAS REPORTED BY THE CUSTOMER THAT THE AMPLE BROKE CAUSING INJURY. WHEN SQUEEZING TO BREAK AMPULE THE GLASS BROKE THROUGH THE PLASTIC AND CUT A STUDENT. HISTORICAL COMPLAINT DATA FOR SKU 261192 SHOWS NO TREND CONCERNING THE REPORTED ISSUE OVER THE PAST YEAR. RETAIN SAMPLES HAVE BEEN RETRIEVED FOR VISUAL INSPECTION, ALL SAMPLES WERE FOUND COMPLIANT WITH PRODUCT SPECIFICATIONS. A BHR (BATCH HISTORY RECORD) REVIEW DID NOT SHOW ANY ISSUES WITH THE AMPULE. NO DEVIATIONS WERE FOUND EITHER DURING THE PRODUCTION PROCESS OR DURING THE FINAL CHECKS FOR LOT RELEASE. NO PHYSICAL RETURNS OR IMAGES WERE PROVIDED FOR ANALYSIS BASED ON THE INVESTIGATION THE COMPLAINT COULD NOT BE CONFIRMED. AS NO COMPLAINT TRENDS ARE PRESENT AT THIS TIME, NO FURTHER ACTION WILL BE TAKEN. BD WILL CONTINUE TO MONITOR TRENDING FOR THIS ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING ONE BD BBL¿ VOGES-PROSKAUER A REAGENT DROPPERS, A STUDENT WAS INJURED WHEN GLASS BROKE THROUGH THE PLASTIC WHILE SQUEEZING THE AMPULE TO OPEN IT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1: INITIAL REPORTER PHONE #: (B)(6). THE MANUFACTURING LOCATION FOR THIS PRODUCT IS RR DONNELLEY. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING ONE BD BBL¿ VOGES-PROSKAUER A REAGENT DROPPERS, A STUDENT WAS INJURED WHEN GLASS BROKE THROUGH THE PLASTIC WHILE SQUEEZING THE AMPULE TO OPEN IT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.