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

Catalog Number 442020

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 3221276.Medical device expiration date: 15-05-2024.Device manufacture date: 09-08-2023.Initial reporter address: (b)(6).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¿ peds plus¿/ f culture vials (plastic), contamination of bacillus altitudinis and pumilus had been identified in vials across two lot numbers.Nineteen (19) vials were reported in total across aerobic and pediatric blood culture vials; however, a breakdown was not provided.No patient impact reported.

Manufacturer Narrative

H.6.Investigation summary: catalog 442020.Batch no.3221276.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.Catalog 442020.Batch no.3188331.Customer reported a contamination issue while using bactec product.Neither photos nor returned good samples were received.Upon further evaluation it was noticed that complaint received was from a product already expired.Investigation cannot be conducted to the retention samples since the product is already expired.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.The batch history record was not reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.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.Do not use culture vials past their expiration date.Complaint is unconfirmed.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¿ peds plus¿/ f culture vials (plastic), contamination of bacillus altitudinis and pumilus had been identified in vials across two lot numbers.Nineteen (19) vials were reported in total across aerobic and pediatric blood culture vials; however, a breakdown was not provided.No patient impact reported.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ 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: 19112084
• MDR Text Key: 340900058
• Report Number: 2647876-2024-00063
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: (01)00382904420208
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151866
• 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: 05/06/2024

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: 04/06/2024
• Device Catalogue Number: 442020
• Device Lot Number: 3188331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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