MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM; DEVICE, GAS GENERATING

Model Number	260678
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).Initial reporter addr 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd gaspak¿ ez anaerobe container system that there was a label issue.The following information was provided by the initial reporter: confirm if the lot of the box and lot of the envelopes in the catalog is normal that they are not the same.
Event or Problem Description
It was reported that while using the bd gaspak¿ ez anaerobe container system that there was a label issue.The following information was provided by the initial reporter: confirm if the lot of the box and lot of the envelopes in the catalog is normal that they are not the same.
Additional Manufacturer Narrative
H.6 investigation summary: a complaint investigation due to incorrect labeling on gaspak ez anaerobe container catalog 260678 batch no.: 2055996 was performed on retention samples.Returned goods were not received from customer.The investigation required to perform visual inspection, incoming and batch record review.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Incoming record not available, lot received under skip lot program.Photo received from customer was evaluated.No discrepancy observed.Raw material batch number 1272lj was used to manufacture bd batch 2055996.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.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.

• Brand Name: BD GASPAK¿ EZ ANAEROBE CONTAINER 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: 16550412
• Report Number: 1119779-2023-00289
• Device Sequence Number: 17628861
• Product Code: KZJ
• UDI-Device Identifier: 30382902606780
• UDI-Public: 30382902606780
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,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 Expiration Date: 07/01/2023
• Device Model Number: 260678
• Device Catalogue Number: 260678
• Device Lot Number: 2055996
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 04/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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