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

Catalog Number	297354
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while testing with bd bbl¿ trypticase¿ soy broth contamination was discovered before use.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: it was reported that upon removal of nested tubes from box, a tube with turbidity and particulates was found.This was unopened by the qc micro team, customer problem: complaint received via vwr on behalf of their customer and states the following: "upon removal of nested tubes from box, a tube with turbidity and particulates was found.This was unopened by the qc micro team, 1.Of the 20 packs, only 6 have been inspected and 1 found with the defect.2.Quantity received and quantity affected: 20 packs received, 1 tube affected.
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.
Additional Manufacturer Narrative
Investigation summary: 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 batch1182045 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, 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.Retention samples from batches 1182045 (10 tubes) were available for inspection.No microbial growth or particles were observed in 10/10 retention samples from visual inspection.For further investigation of contamination, two retention samples went into incubation.One retention tube went into 20-25-degrees celsius incubator, and one retention tube went into 33-37-degrees celsius incubator.At seven days incubation, no microbial growth or particles were observed from 2/2 retention tubes.Six photos were received to assist with the investigation.Four photos each show the bottom half of a partial tube with media that does appear hazy with possible contamination.No product information is presented in these photos.The other two photos each show half of a tube label from batch 1182045 for batch verification.No returns were received to assist with the investigation.The hazy media is observed in the photos however, the haziness could not be identified from the photos.This complaint can be confirmed by the photos provided.No complaint trends for contamination have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination.
Event or Problem Description
It was reported while testing with bd bbl¿ trypticase¿ soy broth contamination was discovered before use.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: it was reported that upon removal of nested tubes from box, a tube with turbidity and particulates was found.This was unopened by the qc micro team, § customer problem: complaint received via vwr on behalf of their customer and states the following: "upon removal of nested tubes from box, a tube with turbidity and particulates was found.This was unopened by the qc micro team, 1.Of the 20 packs, only 6 have been inspected and 1 found with the defect.2.§ quantity received and quantity affected: 20 packs received, 1 tube affected.

• 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: 14568501
• Report Number: 1119779-2022-00786
• Device Sequence Number: 17663545
• Product Code: JSG
• UDI-Device Identifier: 00382902973546
• UDI-Public: 00382902973546
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/04/2022

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: Other
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: 297354
• Device Lot Number: 1182045
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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