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

Model Number 442023

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

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

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

Customer stated issues happened in both (b)(6) and (b)(6) with no definite dates of event.Awareness date from global complaint was used here.Medical device expiration date: unknown.Medical device lot #: unknown.Device manufacture date: unknown.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¿ plus aerobic/f culture vials (plastic) there was possible contamination with three blood culture bottles.There was three patients with the same organism (2 in may, 1 in july) and additional blood culture bottles were ordered and were negative.Results were reported to the doctors and it has not been confirmed the results were erroneous but the customer is considering all possibilities as this is very unusual to them.Treatment was initiated as patients were critically ill-outside of the one culture of stenotrophomonas.Adverse impact to patients is unknown as customer did not provide response.The following information was provided by the initial reporter: customer is reporting a possible contamination with blood culture bottles (442023).

Manufacturer Narrative

H.6 investigation summary: 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.Ba complaint history review was conducted, and batch has been previously investigated for the reported defect.No trend identified.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 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.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 442023; batch no.1321555.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.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 while using bd bactec¿ plus aerobic/f culture vials (plastic) there was possible contamination with three blood culture bottles.There was three patients with the same organism (2 in may, 1 in july) and additional blood culture bottles were ordered and were negative.Results were reported to the doctors and it has not been confirmed the results were erroneous but the customer is considering all possibilities as this is very unusual to them.Treatment was initiated as patients were critically ill-outside of the one culture of stenotrophomonas.Adverse impact to patients is unknown as customer did not provide response.The following information was provided by the initial reporter: customer is reporting a possible contamination with blood culture bottles (442023).

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) there was possible contamination with three blood culture bottles.There was three patients with the same organism (2 in may, 1 in july) and additional blood culture bottles were ordered and were negative.Results were reported to the doctors and it has not been confirmed the results were erroneous but the customer is considering all possibilities as this is very unusual to them.Treatment was initiated as patients were critically ill-outside of the one culture of stenotrophomonas.Adverse impact to patients is unknown as customer did not provide response.The following information was provided by the initial reporter: customer is reporting a possible contamination with blood culture bottles.(442023).

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15161358
• MDR Text Key: 304979219
• Report Number: 1119779-2022-01061
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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