MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM; DEVICE, GAS GENERATING

Model Number 260626

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

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

It was reported that bd bbl¿ gaspak¿ 100 anaerobic system experiencing growth issues when using gaspak system.No injuries were reported.The following information was provided by the initial reporter: customer reported they are experiencing growth issues when using the gaspak system.

Manufacturer Narrative

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

Manufacturer Narrative

H.6 investigation summary: a complaint investigation due to growth failure on gaspak 100 system catalog 260629 was performed.Returned goods were not received from customer.The investigation required to evaluate qn and complaint history.No trend was observed in a period of one year.Batch record review unable to investigate due to batch number was not received from customer.No corrective action is required based on information evaluated.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.

Event Description

It was reported that bd bbl¿ gaspak¿ 100 anaerobic system experiencing growth issues when using gaspak system.No injuries were reported.The following information was provided by the initial reporter: customer reported they are experiencing growth issues when using the gaspak system.

• Brand Name: BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM
• Type of Device: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16513363
• MDR Text Key: 311347295
• Report Number: 1119779-2023-00262
• Device Sequence Number: 1
• Product Code: KZJ
• UDI-Device Identifier: 00382902606260
• UDI-Public: 00382902606260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 04/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 260626
• Device Catalogue Number: 260626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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