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

Catalog Number 445220

Device Problem Leak/Splash (1354)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that while using bd bactec plus aerobic/f culture vials (plastic) - current formulation, the bottle popped out during use and blood leaked out of the bottle.No patient impact reported.Blood was cleaned according to hospital protocol.

Event Description

It was reported that while using bd bactec plus aerobic/f culture vials (plastic) - current formulation, the bottle popped out during use and blood leaked out of the bottle.No patient impact reported.Blood was cleaned according to hospital protocol.

Manufacturer Narrative

H6.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 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 unconfirmed based on retention samples and batch history records.The capper sealing and spinning sections are evaluated prior to the manufacturing process of each lot and verifications of cap seal are performed by technicians during each run.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 h10.

• Brand Name: BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) - CURRENT FORMULATION
• 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: 18534262
• MDR Text Key: 333118740
• Report Number: 2647876-2024-00008
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904452209
• UDI-Public: (01)00382904452209
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K222591
• 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: 02/12/2024

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: 04/01/2024
• Device Catalogue Number: 445220
• Device Lot Number: 3179727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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