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

Catalog Number	260683
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
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 bd gaspak¿ ez anaerobe gas generating pouch 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: customer reports a lack of growth when using gaspak 260683.Customer additionally reports that after 2 days of incubation the sachets display black dots similar to mold.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval? yes.D9: returned to manufacturer on: 27-apr-2022.H6: investigation summary a complaint investigation, due to lack of growth and black dots on gaspak ez anaerobe pouch w indicator catalog 260683 batch no.: 2007649, was performed on retention samples and returned goods.The investigation required to perform anaerobic reduction, microbiological performance, gas concentration test, visual inspection, incoming and batch record review.Since returned good were received already activated they were unable to be further investigated.Performance test as well as visual inspection was not performed.Large dark dots were observed on activated sachet.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Based on information evaluated and results obtained, complaint is unable to be confirmed for contamination.Complaint has been confirmed for a cosmetic defect based on the photos provided and returned samples.Condensation, extra moisture in the bag or plate temperature changes can affect appearance of sachets.
Event or Problem Description
It was reported that while using bd gaspak¿ ez anaerobe gas generating pouch 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: customer reports a lack of growth when using gaspak 260683.Customer additionally reports that after 2 days of incubation the sachets display black dots similar to mold.

• 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: 14322755
• Report Number: 2647876-2022-00132
• Device Sequence Number: 4677063
• Product Code: KZJ
• UDI-Device Identifier: 00382902606833
• UDI-Public: 00382902606833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 01/05/2023
• Device Catalogue Number: 260683
• Device Lot Number: 2007649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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