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

Model Number 221716

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/28/2021

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 4 bd bbl¿; trypticase¿; soy broth the labels were not attached.

Manufacturer Narrative

Investigation summary: material 221716 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 0281029 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and packaging processes were within specifications.The labeling process for material 221716 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 0281029 does not show an excess of labels after manufacturing which would support the incidence of a tube without a label.Qc inspection and testing was satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for missing labels.Retention samples from batch 0281029 (10 tubes) were available for inspection.No cap, or tube label defect was observed in 10/10 retention samples.All 10/10 retentions tubes had a properly affixed label.No photos or returns were received to assist with the investigation.Bd will continue to trend complaints for labeling.This complaint cannot be confirmed.

Event Description

It was reported that prior to use with 4 bd bbl¿; trypticase¿; soy broth the labels were not attached.

• Brand Name: BD BBL; TRYPTICASE; SOY BROTH
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11351614
• MDR Text Key: 243743868
• Report Number: 1119779-2021-00332
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: 30382902217160
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 06/28/2021

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
• Device Operator: Other
• Device Expiration Date: 03/26/2022
• Device Model Number: 221716
• Device Catalogue Number: 221716
• Device Lot Number: 0281029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1