MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256089

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that the patient was exposed to the positive control reagent of bd rapid detection of sars-cov-2 veritor¿.This is a report of one occurrence.No false results were reported for to the patient or the clinician.Exposure to this the control reagent would not cause the patient to contract covid-19 but could result in a false positive to the patient.The following information was provided by the initial reporter: "it was reported that there was exposure to reagent.Customer problem: customer called in and inquired about the composition of the positive control swab.She wants to know if it can have any harmful effect on patient.The patient had been mistakenly inserted the positive control swab in his nose instead of a normal nasopharyngeal test swab.The test was ran again shortly after the discovery of that mistake.The customer is wondering if the positive cov-2 result she obtained is due to the positive control swab that was inserted previously.I read the sds to her and sent it as well.From what i read to her, i told her i do not believe that it will harm the customer however, she should follow the precaution measures mentioned in the sds.An email was sent to mis to reach out to her about her second question on whether the use of this positive control swab could have led to the positive cov-2 results she obtained.Emerson lovell from mis responded to her and said that "regarding the positive control swabs potential to cause a positive result.The control swab contains recombinant protein which cannot make you sick, but could result in a positive test outcome.If you are not symptomatic, you could retest 24 - 48 hours later or you could take a pcr test" customer is inquiring on the component of positive control swab and if inserted inside of patient' nose can it lead to to a positive cov-2 result".

Manufacturer Narrative

Medical device expiration date: none, medical device serial # unknown, medical device batch#: unknown, (b)(4).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the patient was exposed to the positive control reagent of bd rapid detection of sars-cov-2 veritor¿.This is a report of one occurrence.No false results were reported for to the patient or the clinician.Exposure to this the control reagent would not cause the patient to contract covid-19 but could result in a false positive to the patient.The following information was provided by the initial reporter: "it was reported that there was exposure to reagent.Customer problem: customer called in and inquired about the composition of the positive control swab.She wants to know if it can have any harmful effect on patient.The patient had been mistakenly inserted the positive control swab in his nose instead of a normal nasopharyngeal test swab.The test was ran again shortly after the discovery of that mistake.The customer is wondering if the positive cov-2 result she obtained is due to the positive control swab that was inserted previously.I read the sds to her and sent it as well.From what i read to her, i told her i do not believe that it will harm the customer however, she should follow the precaution measures mentioned in the sds.An email was sent to mis to reach out to her about her second question on whether the use of this positive control swab could have led to the positive cov-2 results she obtained.Emerson lovell from mis responded to her and said that "regarding the positive control swabs potential to cause a positive result.The control swab contains recombinant protein which cannot make you sick, but could result in a positive test outcome.If you are not symptomatic, you could retest 24 - 48 hours later or you could take a pcr test" customer is inquiring on the component of positive control swab and if inserted inside of patient' nose can it lead to to a positive cov-2 result".

Manufacturer Narrative

Investigation summary: this memo is to summarize the investigation results regarding your complaint that alleges exposure to reagent when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number unknown.Bd quality performs a systematic approach to investigate exposure to reagent complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.An investigation could not be performed as no batch number was provided.The reported issue was unable to be confirmed.The root cause could not be identified.No trend against exposure to reagent was identified.Currently no adverse trend for exposure to reagent was identified.Bd quality will continue to closely monitor for trends.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• 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: 13999485
• MDR Text Key: 288776568
• Report Number: 1119779-2022-00501
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00382902560890
• UDI-Public: 382902560890
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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
• Device Operator: Other
• Device Catalogue Number: 256089
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/20/2022
• 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): Other