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 06/16/2022

Event Type  malfunction  

Event Description

It was reported that while using 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: sticker is loose, skewed, and not attached to the sticker.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default 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 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: "sticker is loose, skewed, and not attached to the sticker.".

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 1251628 was satisfactory per internal procedures.Formulation, labeling, and packaging processes were within specifications.The labeling process for material 245122 includes label reconciliation where the total number of labels issued is reconciled with the total quantity of labels applied to tubes, used in the batch history record, rejected and unused.Any discrepancies must be within allowable limits specified in the labeling control procedure.The label reconciliation for batch 1251628 does not show an excess of labels after manufacturing which would support the incidence of a tube without a label.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaint has been taken on this batch.Retention samples from batch 1251628 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention samples.All retention tubes had properly affixed legible tube labels and scannable barcode labels.Five photos were received to assist with the investigation: the first photo shows one tube without a label.The second photo shows one tube from batch 1251628.The scannable barcode label is peeling off the tube.The third photo shows one tube.The label is lifting off the tube.The fourth photo shows one tube the label position on the tube appears to be shifted and lifting off the tube.The last photo shows one tube from batch 1251628, the label position is shifted and appears to be lifting from the tube.No returns were received to assist with the investigation.This complaint can be confirmed for missing label and label positioning based on the evidence provided by the photos.Bd will continue to trend complaints for missing tube labels, and label positioning.Notes: risk management review indicates the potential risks of the defects reported were assessed as severity [s1], per [baltrmlmbactecmgitaph ], rev [03], id [7.1] for [missing label] and severity [s1], per [baltrmlmbactecmgitaph ], rev [03], id [6.2] for [label position].

• 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: 15033602
• MDR Text Key: 302001787
• Report Number: 1119779-2022-01004
• 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: 08/30/2022

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: 03/05/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1251628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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