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

Model Number	260001
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while using 6 bd gaspak¿ ez anaerobe container system with indicator mold contamination 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: "in terms of the sachets they appear to be contaminated prior to being used.They look mouldy to me from the images & the customer said they appeared to be contaminated prior to use".
Event or Problem Description
It was reported that while using 6 bd gaspak¿ ez anaerobe container system with indicator mold contamination 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: "in terms of the sachets they appear to be contaminated prior to being used.They look mouldy to me from the images & the customer said they appeared to be contaminated prior to use.".
Additional Manufacturer Narrative
H6: investigation summary a complaint investigation for gaspak ez anaerobe container w indicator batch no.: 0335627 was performed on retention samples and returned goods.The investigation required to perform anaerobic reduction, microbiological performance, gas concentration test, condensate time, visual inspection, incoming and batch record review.Returned goods and retention samples performed as expected.Brown speck observed on retention samples and returned goods during the visual inspection.However, this does not affect the product performance.Refer to supplier letter attached.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.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.

• Brand Name: BD GASPAK EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR
• Common Device Name: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 12025877
• Report Number: 3008352382-2021-00166
• Device Sequence Number: 14588582
• Product Code: KZJ
• UDI-Device Identifier: 30382902600016
• UDI-Public: 30382902600016
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/13/2021

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: 03/01/2022
• Device Model Number: 260001
• Device Catalogue Number: 260001
• Device Lot Number: 0335627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1