MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442022

Device Problem Contamination (1120)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) were contaminated which led to false patient results.Additional blood culture testing was performed, and the results were negative.Three patients were treated with bactrim based on the false results, but there was no report of adverse impact.The following information was provided by the initial reporter: erroneous results and adverse effect: were erroneous results and event reported? we are concerned the results were erroneous.How many false positives/negatives did the customer receive? we have 3 patients with same organism (2 in (b)(6), 1 in (b)(6)) what confirmatory testing was performed that determined the results were erroneous? more blood cultures ordered and were negative.Were any erroneous results reported to the doctors? yes- it has not been confirmed the results were erroneous but we are considering all possibilities as this is very unusual.If yes, were any patients treated based on erroneous results? treatment was initiated as patients were critically ill-outside of the one culture of stenotrophomonas if yes, did the erroneous treatment have any adverse impact to the patient(s)? na.Has this organism been reported and any treatment was initiated based on this result? all patients were treated with bactrim and all 3 patient¿s were in the icu-different rooms, no additional cultures growing same.

Manufacturer Narrative

The following fields have been corrected: b5: describe event d1: medical device brand name: bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) d2a: common device name: system, blood culturing.D2b: medical device type: mdb.D4: catalog: 442021.Lot # 1314589.Exp date: 31-aug-2022.Udi (b)(4).G5: pma/510(k)# k123903.H.6 investigation summary: 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.H3 other text : see h.10.

Event Description

It was reported that bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) were contaminated which led to false patient results.Additional blood culture testing was performed, and the results were negative.Three patients were treated with bactrim based on the false results, but there was no report of adverse impact.The following information was provided by the initial reporter: erroneous results and adverse effect: ¿ were erroneous results and event reported? we are concerned the results were erroneous.¿ how many false positives/negatives did the customer receive? we have 3 patients with same organism (2 in may, 1 in july).¿ what confirmatory testing was performed that determined the results were erroneous? more blood cultures ordered and were negative: ¿ were any erroneous results reported to the doctors? yes- it has not been confirmed the results were erroneous but we are considering all possibilities as this is very unusual.¿ if yes, were any patients treated based on erroneous results? treatment was initiated as patients were critically ill-outside of the one culture of stenotrophomonas ¿ if yes, did the erroneous treatment have any adverse impact to the patient(s)? na ¿ has this organism been reported and any treatment was initiated based on this result? all patients were treated with bactrim and all 3 patient¿s were in the icu-different rooms, no additional cultures growing same.

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15352776
• MDR Text Key: 305687478
• Report Number: 2647876-2022-00190
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123903
• 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
• Report Date: 11/08/2022

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: 08/31/2022
• Device Model Number: 442022
• Device Catalogue Number: 442021
• Device Lot Number: 1314589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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