MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL MGIT PANTA ANTIBIOTIC MIXTURE, LYOPHILIZED; SYSTEM, BLOOD CULTURING

Model Number	245114
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k974883.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that prior to use with bd bbl¿ mgit¿ panta¿ antibiotic mixture, lyophilized fungal contamination was discovered.The following information was provided by the initial reporter: the tb lab staff went to reconstitute a vial of panta lot 0149921 with the growth supplement lot 0149929 and noted what appears to be a fungal ball of contamination that was in the liquid supplement and was transferred to the panta when reconstituting it.
Event or Problem Description
It was reported that prior to use with bd bbl¿ mgit¿ panta¿ antibiotic mixture, lyophilized fungal contamination was discovered.The following information was provided by the initial reporter: the tb lab staff went to reconstitute a vial of panta lot 0149921 with the growth supplement lot 0149929 and noted what appears to be a fungal ball of contamination that was in the liquid supplement and was transferred to the panta when reconstituting it.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00204 was sent in error.During investigation it was discovered that it wasn't an issue with the panta vial, it was the supplement.This issue was captured on mfr report# 1119779-2021-00205.

• Brand Name: BD BBL MGIT PANTA ANTIBIOTIC MIXTURE, LYOPHILIZED
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11282173
• Report Number: 1119779-2021-00204
• Device Sequence Number: 3544032
• Product Code: MDB
• UDI-Device Identifier: 30382902451144
• UDI-Public: 30382902451144
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954932
• Number of Events Summarized: 1
• Summary Report (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): 03/03/2021

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 Model Number: 245114
• Device Catalogue Number: 245114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1