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

Model Number 221823

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

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy broth, there was contamination of an unspecified number of plates.No patient impact reported.The following information was provided by the initial reporter: "customer reports that they have previous received lots that had contaminated tubes.".

Manufacturer Narrative

Medical device expiration date: unknown a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation summary: material 221823 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.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 customer did not provide a batch number, photos or returns for this complaint investigation.Trending was done on the appropriate databases for trypticase soy broth (tsb 15ml) (material 221823) and no quality notification trends have been identified for this material for broken/cracked tubes or contamination in the last 12 months.The complaint history was reviewed for material 221823 and there are no trends for broken or cracked tubes or contamination in the last 12 months.Bd will continue to trend complaints for these issues.This complaint cannot be confirmed based on material trending.No additional actions are indicated at this time.

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy broth, there was contamination of an unspecified number of plates.No patient impact reported.The following information was provided by the initial reporter: "customer reports that they have previous received lots that had contaminated tubes.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17344398
• MDR Text Key: 320232410
• Report Number: 1119779-2023-00783
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902218235
• UDI-Public: 30382902218235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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 Model Number: 221823
• Device Catalogue Number: 221823
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1