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

Catalog Number 442020

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/18/2023

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 bd bactec¿ peds plus¿/ f culture vials (plastic) contamination was observed in bottles.The following information was provided by the initial reporter: gram to a pediatric blood culture, from the batch that was recently delivered to us, and gram positive bacilli were also observed.We detected that, in some aerobic blood cultures inoculated with samples of patients, when performing the respective gram, it was observed structures that we identify as gram positive bacilli; without however, when sowing these cultures in solid agars, (we use agar blood, chocolate, macconkey, and trypticase soya) did not recover any gram positive bacillus.

Manufacturer Narrative

H.6 investigation summary catalog 442020.Batch no.3090278.Customer reported a false positive and contamination results.Neither photos nor returned good samples were received.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.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 records were reviewed, and all testing were within specification for product release.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.No correctives 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 investigation process.

Event Description

It was reported that bd bactec¿ peds plus¿/ f culture vials (plastic) contamination was observed in bottles.The following information was provided by the initial reporter: gram to a pediatric blood culture, from the batch that was recently delivered to us, and gram positive bacilli were also observed.We detected that, in some aerobic blood cultures inoculated with samples of patients, when performing the respective gram, it was observed structures that we identify as gram positive bacilli; without however, when sowing these cultures in solid agars, (we use agar blood, chocolate, macconkey, and trypticase soya) did not recover any gram positive bacillus.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17561049
• MDR Text Key: 321768349
• Report Number: 3008352382-2023-00116
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• Reporter Country Code: GT
• 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: 12/07/2023

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: 01/04/2024
• Device Catalogue Number: 442020
• Device Lot Number: 3090278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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