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

Model Number 245114

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11282173
• MDR Text Key: 230489644
• Report Number: 1119779-2021-00204
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451144
• UDI-Public: 30382902451144
• Combination Product (y/n): N
• PMA/PMN Number: K954932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 245114
• Device Catalogue Number: 245114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1