MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING

Model Number 245122

Device Problems Contamination (1120); Missing Information (4053)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml the customer claimed that a product defect may have contributed to contamination.This event occurred 1 time(s).The customer also claimed that some of the products did not have a label.This event occurred 1 time(s) there is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: " a total of 6 mycobacterium culture tubes had quality problems, the tube cover was deformed and caused leakage, the lid could not be tightened and caused pollution, no labels.", "due to the high pathogenicity and infectivity of mycobacterium, it is easy to cause pollution, threaten the safety of laboratory personnel, and affect the experimental results and diagnosis effect, the laboratory attaches great importance to it.".

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 bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml the customer claimed that a product defect may have contributed to contamination.This event occurred 1 time(s).The customer also claimed that some of the products did not have a label.This event occurred 1 time(s) there is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: " a total of 6 mycobacterium culture tubes had quality problems, the tube cover was deformed and caused leakage, the lid could not be tightened and caused pollution, no labels.", "due to the high pathogenicity and infectivity of mycobacterium, it is easy to cause pollution, threaten the safety of laboratory personnel, and affect the experimental results and diagnosis effect, the laboratory attaches great importance to it.".

Manufacturer Narrative

H.6 investigation summary material 245122 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 1187176 was satisfactory per internal procedures.Formulation and filling processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures and checks for torque confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for labeling, cap defects, contamination, or leaking.Retention samples from batch 1187176 (100 tubes) were available for inspection.No defects were observed in 100/100 retention samples for labeling, leaking, crooked caps, or contamination.All 100/100 retention samples had properly affixed, legible labels.Further investigation of contamination ten uninoculated tubes were incubated.Five tubes went into the 20-25-degree celsius incubation, and five tubes went into 33-37-degree celsius incubation.At the end of a seven-day incubation period no microbial growth or increased florescence was observed in 10/10 incubated retention tubes.Three photos were received to assist with the investigation: the first photo shows one tube from batch 1187176.The cap cannot be observed thoroughly but the cap appears to be on the tube as expected.The tube has appropriate labeling.The tube does not appear to be contaminated.The fill volume appears to be at the expected amount; however, the evidence of a leaking tube cannot be determined from the photo provided.There is a tube rack with tubes in the background.The second photo shows one tube from batch 1187176.The cap on this tube does appear to be crooked.The media fill does appear to be lower than the expected amount possibly from a tube that leaked.The media does not appear to be contaminated.There is a tube rack with tubes in the background.The last photo shows one tube from batch 1187176.The fill volume level appears at the expected amount.The tube does not appear to be contaminated.The determination of a leaking tube cannot be determined from the photo provided.No returns were received to assist with the investigation.The complaint cannot be confirmed based on the evidence provided by the photos for a tube missing a label or for contamination.This complaint can be confirmed for a crooked cap and leaking based on the evidence provided by the photos.Bd will continue to trend complaints for contamination, crooked caps, leaking, and labeling.Notes risk management review indicates the potential risks of the defects reported were assessed as severity [s1], per [baltrmlmbactecmgitaph ], rev [03], id [6.2] for [crooked caps] and severity [s1], per [baltrmlmbactecmgitaph ], rev [03], id [6.2] for [leaking].Risk management review indicates the potential risks of the defects reported were assessed as severity [s2], per [baltrmlmbactecmgitaph ], rev [03], id [6.2] for [labeling] and severity [number], per [baltrmlmbactecmgitaph ], rev [03], id [6.3] for [contamination].H3 other text : see h.10.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
• 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: 14649607
• MDR Text Key: 301654085
• Report Number: 1119779-2022-00846
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K974883
• 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: 08/29/2022

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: 01/01/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1187176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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