MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED REGULAR; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number	220528
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd ds headquarters in (b)(4) has been listed as oem - (b)(4) is an oem manufacturing site.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 that while the patient was in the emergency room for an unspecified reason, a nasal sample collection was taken using a swab from a bd¿ universal viral transport kit, 3 ml, flocked regular.The patient was discharged and later developed blisters inside their nose in the area where they had been swabbed.The patient later went to their primary care physician for medical evaluation and was given antibiotics.The patient disclosed a preexisting latex allergy.The patient was reported to have made a full recovery.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is not confirmed.An investigation of the dhr as well as the sds for this product shows that latex/dry natural rubber is not present in the product and/or packaging for the product.A review of past complaints for this does not indicate a trend for this issue.A letter has been attached to be provided to the customer.Investigation conclusion: no samples were available.A review of the dhr and sds does not indicate the presence of latex/dry natural rubber.No trend is present.Root cause description: based on the investigation results to date the root cause was not determinate for the defect described in this complaint.Rationale: no capa is necessary as no defect was observed.
Event or Problem Description
It was reported that while the patient was in the emergency room for an unspecified reason, a nasal sample collection was taken using a swab from a bd¿ universal viral transport kit, 3 ml, flocked regular.The patient was discharged and later developed blisters inside their nose in the area where they had been swabbed.The patient later went to their primary care physician for medical evaluation and was given antibiotics.The patient disclosed a preexisting latex allergy.The patient was reported to have made a full recovery.

• Brand Name: BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED REGULAR
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 8224410
• Report Number: 1119779-2018-00017
• Device Sequence Number: 2024743
• Product Code: JSM
• UDI-Device Identifier: 30382902205280
• UDI-Public: 30382902205280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 220528
• Device Lot Number: 181067200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention