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

Model Number	260678
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	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 container system a false positive result was obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device expiration date: 2021-11-01 h4: device manufacture date: 2020-06-25 h6: investigation summary the investigation required to perform anaerobic reduction, microbiological performance, gas concentration test, visual inspection.Retention samples performed as expected.No discrepancies observed during the visual inspection.No product trend identified for catalog 260678.No corrective action is required based on information evaluated.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd gaspak¿ ez anaerobe container system a false positive result was obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD GASPAK EZ ANAEROBE CONTAINER SYSTEM
• Common Device Name: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11426168
• Report Number: 3008352382-2021-00060
• Device Sequence Number: 3835721
• Product Code: KZJ
• UDI-Device Identifier: 30382902606780
• UDI-Public: 30382902606780
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 11/01/2021
• Device Model Number: 260678
• Device Catalogue Number: 260678
• Device Lot Number: 0177957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1