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

Model Number 260001

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event 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 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.".

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
• Type of Device: 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
• MDR Text Key: 300901437
• Report Number: 2647876-2022-00152
• Device Sequence Number: 1
• Product Code: KZJ
• UDI-Device Identifier: 30382902600016
• UDI-Public: 30382902600016
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1