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

Model Number 245122

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml growth without sample inoculation was discovered in tube.

Manufacturer Narrative

H.6.Investigation: this product 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 0231573 was satisfactory and a quality notification were generated during manufacturing and inspection.Formulation, filling, and torqueing processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 0231573 (100 tubes) were available for inspection.The retention samples showed no cap, tube, or media defects in 100/100 tubes from visual inspection.Two photos were received in lieu of returns to assist with the investigation.The first photo shows a tube from batch 0231473.The second photo shows what appears to be a white circular particle.For investigation, a total of ten uninoculated retention tubes wen into incubation.Five tubes were placed in the 33 to 37 degrees celsius incubator and five tubes were placed in the 20 to 25 degrees celsius incubator.No microbial growth or turbidity of the media was seen in 10/10 incubated retention tubes at the end of the incubation period, and under uv light the incubated tubes did not show any increased fluorescence to indicate microbial growth.No microbial growth was observed in the retention samples.The complaint can be confirmed from the photos.

Event Description

It was reported that prior to use with bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml growth without sample inoculation was discovered in tube.

• 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
• MDR Report Key: 11301391
• MDR Text Key: 230973576
• Report Number: 1119779-2021-00276
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/16/2022
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 0231573
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1