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

Catalog Number 260683

Device Problem Contamination (1120)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

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.

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.

Event Description

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.

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.

• Brand Name: BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17830944
• MDR Text Key: 324465577
• Report Number: 2647876-2023-00193
• Device Sequence Number: 1
• Product Code: KZJ
• UDI-Device Identifier: 30382902606834
• UDI-Public: 30382902606834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 260683
• Device Lot Number: 2362162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1