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

Model Number	260683
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	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd gaspak¿ ez anaerobe gas generating pouch system with indicator an atypical reaction was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " anaerobic indicators are checked 4-24hours to ensure anaerobic conditions are achieved.However it has been noted that anaerobic conditions were achieved on this check and somewhere after the 24hour check and the final read the indicator shows that anaerobic conditions were not met.".
Additional Manufacturer Narrative
H.6 investigation summary: a complaint investigation; due to anaerobic conditions not met using gaspak ez anaerobe pouch w indicator catalog 260683 batch no.: 1036144, was performed on retention samples.Returned goods were not received from customer.The investigation required to perform anaerobic reduction, microbiological performance, gas concentration test, 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 showed any evidence of customer claim.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Instruction for use (ifu) established instruction on 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.
Event or Problem Description
It was reported that while using bd gaspak¿ ez anaerobe gas generating pouch system with indicator an atypical reaction was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " anaerobic indicators are checked 4-24hours to ensure anaerobic conditions are achieved.However it has been noted that anaerobic conditions were achieved on this check and somewhere after the 24hour check and the final read the indicator shows that anaerobic conditions were not met.".

• Brand Name: BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR
• Common Device Name: 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: 14877511
• Report Number: 2647876-2022-00164
• Device Sequence Number: 14860643
• Product Code: KZJ
• UDI-Device Identifier: 30382902606834
• UDI-Public: 30382902606834
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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 Expiration Date: 08/01/2022
• Device Model Number: 260683
• Device Catalogue Number: 260683
• Device Lot Number: 1036144
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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