MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC PLUS AEROBIC/F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number	442192
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: catalog 442192.Batch no.Unknown.Bd was not able to perform an investigation since neither lot number nor returned goods samples were available.Batch history records are always reviewed prior product release.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Letter # shq ¿ 170 should be provided to customer.No corrective action were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
Event or Problem Description
It was reported that while using bd bactec¿ plus aerobic/f culture vials a broken bottle that leaked sample was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: an aerobic blood culture bottle broke during transport from the hospital ward to the laboratory.At the awareness day the customer no longer had the lot number available as the bottle had been already disposed of in special waste.

• Brand Name: BD BACTEC PLUS AEROBIC/F CULTURE VIALS
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11644922
• Report Number: 3008352382-2021-00111
• Device Sequence Number: 14234138
• Product Code: MDB
• UDI-Device Identifier: 00382904421922
• UDI-Public: 00382904421922
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2021

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: 442192
• Device Catalogue Number: 442192
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1