MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ LIM BROTH; CULTURE MEDIA, SELECTIVE BROTH

Catalog Number	296266
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
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 that bd bbl¿ lim broth two tubes broke in employee's hands when opening.No patient impact.The following information was provided by the initial reporter: lim broth tubes 296266 - 2 tubes broke in (employee) hands when opening.
Additional Manufacturer Narrative
H.6 investigation summary: material 296266 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 2005284 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torqueing, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other cap defect complaints have been taken on this batch for broken tubes.Retention samples from batch 2005284 (10 tubes) were available for inspection.There was no evidence of broken tubes observed in 10/10 retention samples.Two photos were received to assist with the investigation: ¿ the first photo shows a partial tube from batch 2005284.The tube is inside of a plastic bag the tube does appear to be cracked and leaking inside of the bag.¿ the second photo shows a tube from batch 2005284, inside of a plastic bag.The tube does appear to be broken.No returns were received to assist with the investigation.This complaint can be confirmed from the evidence provided by the photos.No actions are indicated at this time as no trends were observed.Bd will continue to trend complaints for broken tubes.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 broken tubes.H3 other text : see h.10.
Event or Problem Description
It was reported that bd bbl¿ lim broth two tubes broke in employee's hands when opening.No patient impact.The following information was provided by the initial reporter: lim broth tubes 296266 - 2 tubes broke in (employee) hands when opening.

• Brand Name: BD BBL¿ LIM BROTH
• Common Device Name: CULTURE MEDIA, SELECTIVE BROTH
• 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: 14739446
• Report Number: 1119779-2022-00915
• Device Sequence Number: 14886938
• Product Code: JSD
• UDI-Device Identifier: 00382902962663
• UDI-Public: 00382902962663
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K833759
• 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): 08/24/2022

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: 10/21/2022
• Device Catalogue Number: 296266
• Device Lot Number: 2005284
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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