MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR; DEVICE, GAS GENERATING

Model Number	260001
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd gaspak¿ ez anaerobe container system with indicator were contaminated.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: (b)(6).
Event or Problem Description
It was reported that bd gaspak¿ ez anaerobe container system with indicator were contaminated.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: "it has been reported that the customer has opened the boxes to find sachets with contaminants on the outside.The customer has removed the whole batch from use.".
Additional Manufacturer Narrative
H.6.Investigation summary customer complained that gaspak ez container catalog 260001 showed contamination (black spot).Photos received from customer were evaluated.Black spot observed.This is considered cosmetic defect and do not affect product performance.Retention samples did not showed evidence of customer claim.Based on information evaluated, this complaint is confirmed.Complaint will be monitored for trend.

• Brand Name: BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR
• Common Device Name: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14580232
• Report Number: 2647876-2022-00152
• Device Sequence Number: 1996312
• Product Code: KZJ
• UDI-Device Identifier: 30382902600016
• UDI-Public: 30382902600016
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/01/2023
• Device Model Number: 260001
• Device Catalogue Number: 260001
• Device Lot Number: 2007637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown