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

Catalog Number 221716

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter facility name: (b)(6).G5: pma/510(k)#: preamendment.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy broth, there was contamination of 5 tubes.No patient impact reported.The following information was provided by the initial reporter: "this is report about trypticase soy broth contamination.There is a discrepancy in the culture results when culturing the catheter tip.".

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy broth, there was contamination of 5 tubes.No patient impact reported.The following information was provided by the initial reporter: "this is report about trypticase soy broth contamination.There is a discrepancy in the culture results when culturing the catheter tip.".

Manufacturer Narrative

The following fields have been updated with additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on: 18-mar-2024.H.6.Investigation summary: the batch history record review for batch 2272714 was satisfactory per internal procedures.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr was 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 there is one other contamination complaint on batch 2271714.Retention samples were not available for inspection.There were three (3) photos received to assist in the investigation of batch 2272714.Two photos show two slightly hazy tubes, one with labeled batch 2272714.The tube caps were wrapped in parafilm.One photo shows the labeled portion of the tubes with batch 2272714 displayed.Two (2) tubes batch 2272714 were returned in a bag with bubble wrap in a box with returns for three (3) other complaints, with the caps wrapped in parafilm.The tubes were trace hazy and incubated at 35 degrees celsius for 21 days.At 21 days, the incubated returned tubes showed no growth.This complaint cannot be confirmed for appearance based on the photos of hazy media and returned tubes of trace hazy media.The coa for this product, the broth appearance is light yellow to medium tan yellow, clear to trace hazy.This is consistent with the photos and returns received.There was no growth after 21 days incubation bd will continue to trend complaints for contamination.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18150723
• MDR Text Key: 328304121
• Report Number: 1119779-2023-01245
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: (01)30382902217160
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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: 03/23/2024
• Device Catalogue Number: 221716
• Device Lot Number: 2272714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1