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

Catalog Number 442023

Device Problem Leak/Splash (1354)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.E1: initial reporter facility name: (b)(6) hospital there were multiple 510k numbers reported to be involved.The information is as follows: g.5.Pma / 510(k)#: k222591 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¿ plus aerobic/f culture vials (plastic), there were perforations seen on one bottle containing patient blood sample.No patient impact or exposure reported.

Manufacturer Narrative

H.6 investigation summary: catalog: 442023.Batch no.3138183.Customer reported a bottle leakage.Photos of an inoculated bottle was 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 for any resin trapped between the cap and the mouthpiece with satisfactory results (i.E.No resin observed).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 confirmed based on photo received from the customer.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.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.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.

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), there were perforations seen on one bottle containing patient blood sample.No patient impact or exposure reported.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18474837
• MDR Text Key: 332988429
• Report Number: 2647876-2024-00001
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113558
• 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: 01/29/2024

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 Expiration Date: 02/20/2024
• Device Catalogue Number: 442023
• Device Lot Number: 3138183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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