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

Catalog Number	221787
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using bd bbl¿ enriched thioglycollate medium, a staff member was transferring a patient's positive blood culture sample into one (1) glass tube when the neck of the tube broke.The staff member after being cut and pierced, went to a medical institution for a blood test and are being monitored.The patient who had the positive blood culture did not have any information about hbv or hcv infection, so even if the staff member had come into contact with the blood, the risk of infection is thought to be low.
Additional Manufacturer Narrative
Investigation summary - material 221787 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 4213637 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and packaging processes were within specifications.In process checks were performed at the designated intervals.Qc inspection and testing were satisfactory at time of release, which included physical attributes of the tubes.The complaint history was reviewed, and one other complaint has been taken on batch 4213637.Retention samples for batch 4213637 (10 tubes) were available for inspection.There were 0/10 broken or cracked tubes found during inspection.There were no photos or returns available for investigation of this complaint.This complaint cannot be confirmed.No complaint trends have been identified for this product; no actions are indicated at this time.Bd will continue to trend for defects.Bd ships product in temperature-controlled trucks to distribution centers.Distribution centers are provided with shipping and storage guidelines.Mishandling of the product and vibrations during shipping can cause cracked or broken tubes.
Event or Problem Description
It was reported when using bd bbl¿ enriched thioglycollate medium, a staff member was transferring a patient's positive blood culture sample into one (1) glass tube when the neck of the tube broke.The staff member after being cut and pierced, went to a medical institution for a blood test and are being monitored.The patient who had the positive blood culture did not have any information about hbv or hcv infection, so even if the staff member had come into contact with the blood, the risk of infection is thought to be low.

• Brand Name: BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21277513
• Report Number: 1119779-2025-00018
• Device Sequence Number: 7891848
• Product Code: JSG
• UDI-Device Identifier: 30382902217870
• UDI-Public: (01)30382902217870(11)240731(17)250729(10)4213637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K803023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/29/2025
• Device Catalogue Number: 221787
• Device Lot Number: 4213637
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown