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

Catalog Number 260001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd gaspak¿ ez anaerobe container system with indicator, 20 sachets don't produce an anerobic condition.No patient impact reported.The following information was provided by the initial reporter: "the sachets don't produce anaerobic condition.The customer put one sachet with indicator into a jar, after a night they was notice the indicator stay blue.".

Event Description

It was reported that while using bd gaspak¿ ez anaerobe container system with indicator, 20 sachets don't produce an anerobic condition.No patient impact reported.The following information was provided by the initial reporter: "the sachets don't produce anaerobic condition.The customer put one sachet with indicator into a jar, after a night they was notice the indicator stay blue.".

Manufacturer Narrative

H.6 investigation summary a complaint investigation due to sachets don't produce anaerobic condition when using gaspak ez anaerobe container w indicator catalog 260001 batch no.: 2276730 was performed on retention samples.Returned goods were not received from customer.The investigation required to perform anaerobic reduction, microbiological performance, gas concentration test, condensate time, visual inspection, incoming and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Incoming and batch record review did not show any evidence of customer claim.Photo received from customer was evaluated.A very light blue indicator pill was observed.The color appreciation could be affected due to the angle of the picture or picture's illumination.Only one sachet is observed.It could not be confirmed the quantity of sachet used by jar to assure ifu instructions were followed.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Ifu established instruction for product testing and results evaluation.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.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17647305
• MDR Text Key: 322253631
• Report Number: 2647876-2023-00112
• Device Sequence Number: 1
• Product Code: KZJ
• UDI-Device Identifier: 30382902600016
• UDI-Public: 30382902600016
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 260001
• Device Lot Number: 2276730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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