BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR
Received Sep 28, 2023 · Event occurred Sep 6, 2023
Report 2647876-2023-00193 · MDR key 17830944
Device
Generic name
Device, Gas Generating
Manufacturer
Becton Dickinson Caribe Ltd.Catalog number
260683
Lot number
2362162
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS POSSIBLE CONTAMINATION.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2647876-2023-00193 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS POSSIBLE CONTAMINATION.
Additional Manufacturer Narrative
G.1 INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.