MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/06/2022

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown, udi number: unknown, device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(4) has been listed and the sparks fda registration number has been used for the manufacture report number.

Event Description

It was reported that after use with a bd veritor swab, the patient experienced an allergic reaction and sought medical attention.The following information was provided by the initial reporter: we saw a patient in clinic for swelling of her eyes 15 minutes after swabbing herself using the swab in the bd veritor art kit.I called the patient.She was quite sure, she did not dip the swab stick into the solution before swabbing her nose.She did not take any other medications or new food and was well in herself.I have also discussed this with my ear nose and throat doctor colleague.As this is only a superficial art ( vs deeper pcr), it is also unlikely to cause such a reaction.It was her first time using bd art kit.She has since tolerated other art kit from other companies.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges an allergic reaction or swelling of eyes 15 minutes after swabbing when using the bd veritor art kit (material # unknown), batch number unknown.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation could not be performed because the product and batch number were not provided.The complaint was unable to be confirmed.The root cause could not be identified.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.H3 other text : see h.10.

Event Description

It was reported that after use with a bd veritor swab, the patient experienced an allergic reaction and sought medical attention.The following information was provided by the initial reporter: we saw a patient in clinic for swelling of her eyes 15 minutes after swabbing herself using the swab in the bd veritor art kit.I called the patient.She was quite sure, she did not dip the swab stick into the solution before swabbing her nose.She did not take any other medications or new food and was well in herself.I have also discussed this with my ear nose and throat doctor colleague.As this is only a superficial art ( vs deeper pcr), it is also unlikely to cause such a reaction.It was her first time using bd art kit.She has since tolerated other art kit from other companies.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 13999429
• MDR Text Key: 288776097
• Report Number: 1119779-2022-00500
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female