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

Catalog Number 442022

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) 15 false positive occurred.1 of these false results was reported to the clinician and the patient.The following information was provided by the initial reporter: in our hospital routine, blood samples for culture are collected in bottles 442023/bd bactec plus aerobic medium or 442022/bd bactec plus anaerobic medium and incubated in the bactec 9240 equipment.Blood cultures detected as positive by the system are immediately smeared and bacterioscopy performed using the gram method.Those in which the presence of gram-positive cocci (ggc) is evidenced within a period of less than 24 hours from the moment of collection or that present gram-negative rods (gnb) are immediately referred to the bcid2 panel.In our current routine, the bcid2 panel kit was received in november 2021 and readily available for use.On (b)(6) 2021, we had the first false positive case for acinetobacter calcoaceticus-baumannii complex and since then we have observed an increasing number of results that detected the microorganism, but they were not recovered in traditional cultures.We observed a total of 15 false positive results for acinetobacter calcoaceticus-baumannii complex, all with more than one microorganism detected.There were 13 gram negative bacteria results, one with gram positive and one with an association between the two.Among the false positives, we followed two important cases (details of cases within recs (b)(6) and (b)(6)) that occurred in parallel.An october 2021 u.S food and drug administration (fda) advisory was found for blood culture identification 2 (bcid2) recall number z-0312-2022, recall event id 88934.According to the advisory, the recall was made due to false positive increase for results for acinetobacter calcoaceticus-baumannii complex, related to non-viable contamination of culture vials.The bottles used in our laboratory routine have the same references highlighted in the american regulatory document.Distributor report: we received a notification from the customer about false positivity of acinetobacter in blood culture bottles.The blood culture batches used by the client in the exams that presented this situation were 1167767 and 1181333 (pr#(b)(4)) / 1167259 and 1175560 (pr# (b)(4)).".Patient"."hospitalized in the dermatology section with peylonephritis.Blood culture was collected on (b)(6) 2022, positivity was detected by bactec at dawn on (b)(6) 2022 and filmarray bcid2 was performed.Although the equipment detected positive for acinetobacter calcoaceticus-baumannii complex and e.Coli, the report was released as not performed for acinetobacter calcoaceticus-baumannii complex and positive only for e.Coli.In view of the result, the medical team started the treatment of the patient with ceftriaxone.In a culture-dependent method, only the growth of a microorganism identified and released as e.Coli was observed.After a discussion with a member of the ccih, the medical team reported that the patient was progressing well, with decreasing crp and afebrile for 3 consecutive days.(b)(6): (b)(6) 2022 11:44:03 (gmt).Bottle sequence number: 449356730480.Lot 1167259.Verified with rcc a total of 15 false positives over pr's (b)(4) and (b)(4) (2 material #'s and 4 lot #'s) - this pr is for (b)(4).

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) 15 false positive occurred.1 of these false results was reported to the clinician and the patient.The following information was provided by the initial reporter: in our hospital routine, blood samples for culture are collected in bottles (b)(4)/bd bactec plus aerobic medium or (b)(4)/bd bactec plus anaerobic medium and incubated in the bactec 9240 equipment.Blood cultures detected as positive by the system are immediately smeared and bacterioscopy performed using the gram method.Those in which the presence of gram-positive cocci (ggc) is evidenced within a period of less than 24 hours from the moment of collection or that present gram-negative rods (gnb) are immediately referred to the bcid2 panel.In our current routine, the bcid2 panel kit was received in (b)(6) 2021 and readily available for use.On (b)(6), 2021, we had (b)(4) false positive case for acinetobacter calcoaceticus-baumannii complex and since then we have observed an increasing number of results that detected the microorganism, but they were not recovered in traditional cultures.We observed a total of (b)(4) false positive results for acinetobacter calcoaceticus-baumannii complex, all with more than one microorganism detected.There were 13 gram negative bacteria results, one with gram positive and one with an association between the two.Among the false positives, we followed two important cases (details of cases within recs (b)(4)) that occurred in parallel.An (b)(6) 2021 u.S food and drug administration (fda) advisory was found for blood culture identification 2 (bcid2) recall number z-0312-2022, recall event id (b)(4).According to the advisory, the recall was made due to false positive increase for results for acinetobacter calcoaceticus-baumannii complex, related to non-viable contamination of culture vials.The bottles used in our laboratory routine have the same references highlighted in the american regulatory document.Distributor report: we received a notification from the customer about false positivity of acinetobacter in blood culture bottles.The blood culture batches used by the client in the exams that presented this situation were (b)(6) (pr#(b)(4)) / (b)(6) (pr# (b)(4)).".Patient"."hospitalized in the dermatology section with peylonephritis.Blood culture was collected on (b)(6), 2022, positivity was detected by bactec at dawn on (b)(6), 2022 and filmarray bcid2 was performed.Although the equipment detected positive for acinetobacter calcoaceticus-baumannii complex and e.Coli, the report was released as not performed for acinetobacter calcoaceticus-baumannii complex and positive only for e.Coli.In view of the result, the medical team started the treatment of the patient with ceftriaxone.In a culture-dependent method, only the growth of a microorganism identified and released as e.Coli was observed.After a discussion with a member of the ccih, the medical team reported that the patient was progressing well, with decreasing crp and afebrile for 3 consecutive days.(b)(6) : (b)(6) 2022 11:44:03 (gmt) bottle sequence number: (b)(4).Lot 1167259.Verified with rcc a total of (b)(4) positives over pr's (b)(4) (2 material #'s and 4 lot #'s) - this pr is for (b)(4).

Manufacturer Narrative

H.6.Investigation: customer reported a positive id result for bactec media, while using biofire filmarray® blood culture identification bdic/bcid2 panels.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 could not be reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.No investigation can be conducted to the retention samples since the product is already expired.Complaint is unconfirmed.As per product insert a gram-stained smear from culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.Due to the nature of biological materials in media products and inherent organism variability, the user should be cognizant of potential variable results in the recovery of certain microorganisms.Molecular tests performed on positive blood cultures will detect both viable and non-viable organisms commonly found in culture media.Therefore, molecular test results should be evaluated in conjunction with gram stain results in accordance with standard-of-care practices as well as manufacturer¿s instructions for use.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.

• Brand Name: BD BACTEC¿ PLUS 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: 14311179
• MDR Text Key: 290950590
• Report Number: 2647876-2022-00129
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 382904420222
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141810
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 442022
• Device Lot Number: 1167259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female