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

Model Number	297354
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
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 by the customer that while using bd bbl¿ trypticase¿ soy broth the customer received 3 boxes that were contaminated.There is no confirmatory testing reported.There is no patient impact reported.The following information was provided by the initial reported, "when we received the 3 remaining boxes on (b)(6) 2022, each had some media tubes that were contaminated.".
Additional Manufacturer Narrative
H.6: complaints investigation.Material 297354 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 reviews for batch 2075857 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.In process checks are performed during manufacturing at designated intervals per procedures.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure and fill volumes were within specification.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhrs are 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 for any defect.Retention samples from batch 2075857 (10 tubes) were available for inspection.No low fill volumes or microbial growth were observed in 10/10 retention samples.For investigation, two retention tubes were incubated.One tube was placed in the 33-37 degree c incubator and one tube was placed into the 20-25 degree c incubator for seven days.At the seven days incubation, neither tube showed any signs of microbial growth or change in media appearance.Four photos were received to assist with the investigation: the first photo shows a partial ,opened bd carton.A partial tube rack and tube can be seen.The second photo shows an opened, partial carton.The bottom of seven tubes in a tube rack can be observed.Three of the visible tubes have clear media as expected.Four of the visible tubes have turbid media that appears to be from contamination.Two of the turbid tubes also have fill volume that is less than expected.No product information is presented in this photo.The third photo shows an opened 100-pack bd carton.Eight tubes from batch 2075857 can be observed from the photo.Four tubes have turbid media that could be from contamination.Two of the turbid tubes appear to also have low fill volume.The last photo shows a partial bd 100-pack carton from batch 2075857, carton number 112.Tubes from batch 2075857 are in a tube rack on top of the box.Five tubes have significantly lower fill volumes and the media in one of these tubes also appears to be turbid.No returns were received to assist with the investigation.This complaint can be confirmed for contamination and low fill volume based on the evidence provided in the photos.No complaint trends were identified for contamination or low fill for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination and low fill volume.Notes: risk management review indicates the potential risks of the defects reported were assessed as severity s1, per baltrmterminalgpaph, rev 02, id 18.0 for contamination and severity s1, per baltrmterminalgpaph, rev 02, id 18.1 for fill volume.
Event or Problem Description
It was reported by the customer that while using bd bbl¿ trypticase¿ soy broth the customer received 3 boxes that were contaminated.There is no confirmatory testing reported.There is no patient impact reported.The following information was provided by the initial reported, "when we received the 3 remaining boxes on (b)(6) 2022, each had some media tubes that were contaminated.".

• 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
• 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: 14459138
• Report Number: 1119779-2022-00734
• Device Sequence Number: 4506808
• Product Code: JSG
• UDI-Device Identifier: 30382902973547
• UDI-Public: 30382902973547
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: 297354
• Device Catalogue Number: 297354
• Device Lot Number: 2075857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown