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 Eye Injury (1845)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Eua # (b)(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that while testing with bd rapid detection of sars-cov-2 veritor¿ the cap was loose on tube and when mixing reagent the sample went into the operators eye.Operator sought medical attention and blood tests were performed.Eua # (b)(4).The following information was provided by the initial reporter: operator, was using face shield but had flicked it up as shield had fogged up.As he was processing the test, he placed the dropper lid on top of the reagent tube but cap didn't clip into place (was loose).As he flicked the reagent tube to mix, reagent flicked out and went into the operators eye.Medical practitioner was contacted, ordered saline flush and once complete operator went to medical care for full books, as per any body intrusion injury.

Manufacturer Narrative

H.6.Investigation: this statement is to summarize the investigation results regarding the complaint that alleges operator processed test with loose reagent¿s tube cap while face shield flicked up when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number unknown.Bd quality performs a systematic approach to investigate operator processed test with loose reagent¿s tube cap while face shield flicked up 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.Operator was using face shield but had to flicked it up as the shield had fogged up, while he was processing the test.The operator placed the dropper lid on top of the reagent's tube but the cap didn't clipped into place (was loose).As he flicked the reagent tube to mix, the reagent flicked out and went into the operator's eye.Medical practitioner was contacted, and ordered saline flush and once completed the operator went to medical care for full books, as per anybody intrusion injury.The injury would have been avoided if the face shield was not flicked up during testing and also follow bd's ifu 500050809_ifu_256089_multilingual_en_ca, page 3, the use of personal protective equipment.The complaint was unable to be confirmed.There are no current trends against operator processed test with loose reagent¿s tube cap while face shield flicked up issues.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that while testing with bd rapid detection of sars-cov-2 veritor¿ the cap was loose on tube and when mixing reagent the sample went into the operators eye.Operator sought medical attention and blood tests were performed.Eua # (b)(4) the following information was provided by the initial reporter: operator, was using face shield but had flicked it up as shield had fogged up.As he was processing the test, he placed the dropper lid on top of the reagent tube but cap didn't clip into place (was loose).As he flicked the reagent tube to mix, reagent flicked out and went into the operators eye.Medical practitioner was contacted, ordered saline flush and once complete operator went to medical care for full books, as per any body intrusion injury.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12693321
• MDR Text Key: 279086615
• Report Number: 1119779-2021-01707
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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
• Date Manufacturer Received: 01/13/2022
• 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