MAUDE Adverse Event Report: BECTON DICKINSON BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED FLEXIBLE MINITIP; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number	220531
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed, and the (b)(4) fda registration number has been used for the manufacture report number.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 while using 30 bd¿ universal viral transport kit, 3 ml, flocked flexible minitips sample leakage was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " customer problem: customer reports leaking 220531 tubes after specimen collection.".
Additional Manufacturer Narrative
H.6.Investigation: this statement serves to summarize findings on the recent complaint on product 220531 (kit uvt 3ml with flocked flex minitip), lot number n10175600, where it was observed that the media was leaking from the tube.Event description: " customer reports 220531 swab tubes, lot n10175600, are leaking after specimen collection." 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 did not indicate any manufacturing issues.Sample analysis: the photos did not show the noted defect.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.No complaint trend was present on this issue.However, bd will continue to monitor for trending.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.No further actions will be taken as no confirmed defect has been identified.
Event or Problem Description
It was reported that while using 30 bd¿ universal viral transport kit, 3 ml, flocked flexible minitips sample leakage was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " customer problem: customer reports leaking 220531 tubes after specimen collection.".

• Brand Name: BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED FLEXIBLE MINITIP
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12450949
• Report Number: 2243072-2021-02275
• Device Sequence Number: 3382786
• Product Code: JSM
• UDI-Device Identifier: 30382902205310
• UDI-Public: 30382902205310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/01/2022

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: 10/31/2022
• Device Model Number: 220531
• Device Catalogue Number: 220531
• Device Lot Number: N10175600
• 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: 08/13/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• 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