MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number 442021

Device Problem Leak/Splash (1354)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), the patient's cerebrospinal fluid leaked from one bottle.No patient impact reported.The following information was provided by the initial reporter: "on (b)(6) 2023, when the cerebrospinal fluid was cultured for the patient in the microbiology laboratory of the laboratory department, the anaerobic microbial culture bottle was opened and air bubbles were found at the sealed bottle cap, and the culture bottle leaked, which did not harm the patient.".

Manufacturer Narrative

H.6 investigation summary customer reported a leakage issue.Neither photos nor returned good samples were received.Bd was unable to reproduce customer¿s experience with the bactec product for leakage defect.Satisfactory results were obtained from retention samples when visually inspected.Vacuum draw was performed with satisfactory results.In addition, five (5) samples were randomly selected, and inspected damage caps seal with satisfactory results.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history records.No corrective actions 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.H3 other text : see h.10.

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), the patient's cerebrospinal fluid leaked from one bottle.No patient impact reported.The following information was provided by the initial reporter: "on june 23, 2023, when the cerebrospinal fluid was cultured for the patient in the microbiology laboratory of the laboratory department, the anaerobic microbial culture bottle was opened and air bubbles were found at the sealed bottle cap, and the culture bottle leaked, which did not harm the patient.".

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17467478
• MDR Text Key: 320660547
• Report Number: 2647876-2023-00093
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123903
• 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,Followup
• Report Date: 08/21/2023

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
• Device Operator: Other
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: 442021
• Device Lot Number: 3013295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/06/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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