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

Model Number	260626
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1119779-2023-00262
• Device Sequence Number: 6366951
• Product Code: KZJ
• UDI-Device Identifier: 00382902606260
• UDI-Public: 00382902606260
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2023

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 Model Number: 260626
• Device Catalogue Number: 260626
• Device Lot Number: UNKNOWN
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 04/29/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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