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

Catalog Number 442023

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  

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) contamination was found.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.From the batch of aerobic blood cultures (already expired, however what i report has never happened to us).

Manufacturer Narrative

G5.Pma/510k: k113558, 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.

Manufacturer Narrative

H.6.Investigation summary: customer reported a contamination and false positive result.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 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.The specimen must be collected using sterile techniques to reduce the chance of contamination.Do not use culture vials past their expiration date.Users are cautioned in the package insert under limitation of the procedure: a gram-stained smear from a culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.In addition, the patient specimen may contain organisms that will not grow in the culture medium or in media used for subculture.Such specimens should be subculture to special media as appropriate.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.

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) contamination was found.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.From the batch of aerobic blood cultures (already expired, however what i report has never happened to us).

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547503
• MDR Text Key: 321141383
• Report Number: 3008352382-2023-00117
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: SEE H.10
• 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: 11/19/2023

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: 02/28/2023
• Device Catalogue Number: 442023
• Device Lot Number: 2116479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 11/19/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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