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

Catalog Number 245114

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

It was reported that prior to use of bd bbl¿ mgit¿ panta¿ antibiotic mixture, lyophilized, it was noticed that there was a contaminant in the media.No patient impact reported.

Manufacturer Narrative

D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.E.1 initial reporter facility name: (b)(6) hospital.G.5.Pma / 510(k)#: k974883.H.3.A device evaluation and or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• 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
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18773485
• MDR Text Key: 336755650
• Report Number: 1119779-2024-00142
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K954932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

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 Catalogue Number: 245114
• Device Lot Number: 2322153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1