MalfunctionJTN
DISC PENICILLIN P-10 JAPAN
Received Jul 7, 2026 · Event occurred Jun 11, 2026
Report 2647876-2026-00073 · MDR key 25742980
Device
Generic name
Susceptibility Test Discs, Antimicrobial
Manufacturer
Becton Dickinson Caribe Ltd.Catalog number
296635
Lot number
6030225
Product problems
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING THE DISC PENICILLIN P-10 JAPAN A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANT) RESULT BUT WHEN REPEATED THE RESULT WAS SENSITIVE WITH A COMPETITOR'S MATERIAL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 4.
Additional Manufacturer Narrative
E1. INITIAL REPORTER FACILITY NAME: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.