BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM
Received Mar 9, 2023 · Event occurred Feb 15, 2023
Report 1119779-2023-00262 · MDR key 16513363
Device
Generic name
Device, Gas Generating
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
260626Catalog number
260626
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO GROWTH FAILURE ON GASPAK 100 SYSTEM CATALOG 260629 WAS PERFORMED. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO EVALUATE QN AND COMPLAINT HISTORY. NO TREND WAS OBSERVED IN A PERIOD OF ONE YEAR. BATCH RECORD REVIEW UNABLE TO INVESTIGATE DUE TO BATCH NUMBER WAS NOT RECEIVED FROM CUSTOMER. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.
Description of Event or Problem
IT WAS REPORTED THAT BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM EXPERIENCING GROWTH ISSUES WHEN USING GASPAK SYSTEM. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THEY ARE EXPERIENCING GROWTH ISSUES WHEN USING THE GASPAK SYSTEM.
Description of Event or Problem
IT WAS REPORTED THAT BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM EXPERIENCING GROWTH ISSUES WHEN USING GASPAK SYSTEM. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THEY ARE EXPERIENCING GROWTH ISSUES WHEN USING THE GASPAK SYSTEM.
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.