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

Model Number 245122

Device Problem Missing Information (4053)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: 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 3 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "there is no packaging sticker, so there is no batch number.Quantity: 3 bottles, reason: no packaging sticker (no packaging sticker).".

Manufacturer Narrative

H.6.Investigation: this statement is to summarize findings regarding the complaint related to catalog number 245122, tube bactec mgit 7ml, batch number 0324964, 1078376, 1063896, unknown for empty tubes, cracked tubes, fill volume, label position and missing label.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.Batch 0324964 the batch history record review for batch 0324964 was satisfactory per internal procedures.Filling and packaging 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 empty tube.Retention samples from batch 0324964 (100 tubes) were available for inspection.No media or tube defects were observed in 100/100 retention samples.All 100/100 retention samples had liquid media in each tube.There were no empty tubes found in 100/100 retention samples.No photos were received to assist with the investigation for this batch.Batch: 1078376.The batch history record review for batch 1078376 was satisfactory per internal procedure.Filling, labeling, and packaging processes were within specifications.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 empty tubes, two other complaints have been taken for broken/cracked tubes, and one other complaint has been taken on this batch for fill volume.Retention samples from batch 1078376 (100 tubes) were available for inspection.No empty tubes or broken/cracked tubes were observed in 100/100 retention tube samples.There were no fill volume defects observed in 100/100 retention samples.For investigation 100/100 retention tubes were measured using fill volume measuring tool.All 100/100 retention samples measured at the acceptable fill line.No photos were received to assist with the investigation for this batch.Batch 1063896.The batch history record review for batch 1063896 was satisfactory per internal procedure.Filling, labeling, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and one other complaint has been taken on this batch for fill volume, and two other complaints have been taken on this batch for labeling.Retention samples from batch 1063896 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention tube samples.All retention tubes had one tube label that had legible batch information and a scannable barcode.All 100/100 retention samples were properly filled with the expected fill of liquid media.For investigation 100 retention tubes were measured using a fill volume measuring tool.All 100/100 retention samples measured at the acceptable fill volume level.No photos were received to assist with the investigation for this batch.Batch unknown.Customer did not provide a batch number, photos or returns for this complaint investigation.Trending was done on the appropriate databases for bactec mgit 7ml (material 245122) and no quality notification trends have been identified for this material for missing tube label in the last 12 months.The complaint history was reviewed for material 245122 and there are no trends for missing labeling in the last 12 months.Bd will continue to trend complaints for this issue.This complaint cannot be confirmed based on material trending.Four photos were received to assist with the investigation: ¿ the first photo shows one tube.The fill volume in the photo does appear lower than expected.No product information is presented in the photo.¿ the second photo shows one tube.The tube appears empty but is difficult to determine from the photo.No product information is presented in the photo.¿ the third photo shows two tubes.The tube on the left, the fill volume does appear to be less than expected.The tube on the right does not have a label.No product information is presented in the photo.¿ the last photo shows three tubes without a label.No product information was presented in the photo.Without proper product verification a photo alone cannot confirm a complaint.A photo must provide the defect, and product information.Product information such as material and batch/lot number must be visible in the photo.No returns were received to assist with the investigation.This complaint cannot be confirmed for any of the batches or the unknown batch.Bd will continue to trend complaints for empty container, cracked/broken tubes, fill volume, and labeling.

Event Description

It was reported that while using 3 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "there is no packaging sticker, so there is no batch number.Quantity: 3 bottles., reason: no packaging sticker (no packaging sticker).".

• 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: 13335102
• MDR Text Key: 287020293
• Report Number: 1119779-2022-00094
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• 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