MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221715
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using 2 bd bbl¿ trypticase¿ soy broth missing label information was observed by the laboratory personnel.There was no indication of improper use and no report of patient impact.
Event or Problem Description
It was reported that while using 2 bd bbl¿ trypticase¿ soy broth missing label information was observed by the laboratory personnel.There was no indication of improper use and no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: material 221715 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 0281025 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed and there are no other complaints on this batch.Retention samples from batch 0281025 (10 tubes) were available for inspection.All retention tubes possessed a single, properly affixed label.The labeling process for material 221715 includes label reconciliation where the total number of labels issued is reconciled with the total quantity of labels applied to tubes, affixed to 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 0281025 shows there was no excess of tube labels after manufacturing to support the incidence of missing tube labels.No photos or returns were received to assist with the investigation.The complaint cannot be confirmed.Bd will continue to trend complaints for labeling.

• Brand Name: BD BBL TRYPTICASE SOY BROTH
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11425706
• Report Number: 1119779-2021-00426
• Device Sequence Number: 11877460
• Product Code: JSG
• UDI-Device Identifier: 30382902217153
• UDI-Public: 30382902217153
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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
• Operator of Device: Other
• Device Expiration Date: 03/26/2022
• Device Model Number: 221715
• Device Catalogue Number: 221715
• Device Lot Number: 0281025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1