MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number	220531
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before using bd¿ universal viral transport kit, 3 ml, flocked flexible minitip a swab was found with mold growing inside.The following information was provided by the initial reporter: reported swab found with mold growing inside.Still fully wrapped.
Additional Manufacturer Narrative
D1: medical device brand name: bd¿ universal viral transport kit, 3 ml, flocked flexible minitip.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 or Problem Description
It was reported that before using bd¿ universal viral transport kit, 3 ml, flocked flexible minitip a swab was found with mold growing inside.The following information was provided by the initial reporter: reported swab found with mold growing inside.Still fully wrapped.
Additional Manufacturer Narrative
H.6 investigation summary event description: " reported mold contamination." complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record does not indicate any manufacturing issues.Sample analysis: an inspection of the photo did show the noted defect.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the photo showed the defect.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.No complaint trend exists.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed on the photo.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.This is an isolated incident.Bd will continue to monitor for trending.H3 other text : see h.10.

• Brand Name: SEE H.10
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17035458
• Report Number: 1119779-2023-00600
• Device Sequence Number: 15051385
• Product Code: JSM
• UDI-Device Identifier: 30382902205310
• UDI-Public: 30382902205310
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K042970
• 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): 09/07/2023

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 Model Number: 220531
• Device Catalogue Number: 220531
• Device Lot Number: N2002300
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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