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

Catalog Number	442020
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k173873 a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Report 1 of 2: it was reported while using bd bactec¿ peds plus¿/ f culture vials (plastic) there was biological contamination seen in one sample identified as candida parapsilosis.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: catalog 442020.Batch no.5114122.Customer reported a contamination issue while using bactec product.Neither photos nor returned good samples were received.Bd was unable to reproduce the customer¿s experience with bactec product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.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 record review results.Product inserts states that care must be taken to prevent contamination of the sample during collection and inoculation into the bd bactec¿ vial.Prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depressed septum, or leakage.Do not use any vial showing evidence of contamination.A contaminated vial could contain positive pressure.If a contaminated vial is used for direct draw, gas or contaminated culture media could be refluxed into the patient¿s vein.Vial contamination may not be readily apparent.Prior to use, the user should examine the vials for evidence of damage or deterioration.Vials that are cracked or leaking, or display turbidity, contamination, or discoloration (darkening) should not be used.The specimen must be collected using sterile techniques to reduce the chance of contamination.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 or Problem Description
Report 1 of 2: it was reported while using bd bactec¿ peds plus¿/ f culture vials (plastic) there was biological contamination seen in one sample identified as candida parapsilosis.No adverse impact was reported regarding the patient or user.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
• Common Device Name: 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23532503
• Report Number: 2647876-2025-00661
• Device Sequence Number: 13032595
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: (01)00382904420208(17)260128(10)5114122
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Expiration Date: 01/28/2026
• Device Catalogue Number: 442020
• Device Lot Number: 5114122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown