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

Catalog Number 256082

Device Problem Expiration Date Error (2528)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Eua # (b)(4).Medical device expiration date: unknown.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 while testing for sars-cov-2 it was discovered that 8 patients were tested with expired kits.3 of the 8 patient results were confirmed by pcr test method.Customer stated confirmatory testing will not be performed on remaining 5 patients.Eua # (b)(4).The following information was provided by the initial reporter: it was reported that the customer did not realize the kits have an expiry date so an expired kit was used to test on some patients.Additionally, the bd sales consultant provided the following additional information: followed up with the customer today.Spoke with customer and she stated she never heard back from their distributor about what lot number of product 256082 they received.She asked to go ahead and close the case.Recommended to the customer that they follow up with those patients for re-testing.Shipment method (directly or via distributor): distributor.If it is a distributor ¿ who is it? mckesson.Called the customer today to follow up.She stated that they investigated the incident a little further and provided the updated information below.She also stated that 3 out of the 8 test results were confirmed by pcr but they will not be conducting any re-tests on the other 5 patients.The box of the expired kits were already discarded so she doesn't have the kit lot number available but she is waiting to hear from their distributor if they have it in their records.I will follow up with the customer in a couple of days for the kit lot number.Quantity received and quantity affected: 8 out of 30.If consumable is tested on bd instrumentation, list serial numbers: (b)(4).

Manufacturer Narrative

H6: investigation summary: this memo is to summarize the investigation results regarding your complaint that alleges expired material when using bd kit rapid detection of sars-cov-2 veritor (material # 256082), batch number unknown.Bd quality performs a systematic approach to investigate expired material 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 as no batch number was provided.There are no current trends against expired material complaints.Bd quality will continue to closely monitor for trends.

Event Description

It was reported while testing for sars-cov-2 it was discovered that 8 patients were tested with expired kits.3 of the 8 patient results were confirmed by pcr test method.Customer stated confirmatory testing will not be performed on remaining 5 patients.Eua # (b)(4).The following information was provided by the initial reporter: it was reported that the customer did not realize the kits have an expiry date so an expired kit was used to test on some patients.Additionally, the bd sales consultant provided the following additional information: followed up with the customer today.Spoke with customer and she stated she never heard back from their distributor about what lot number of product 256082 they received.She asked to go ahead and close the case.Recommended to the customer that they follow up with those patients for re-testing.Shipment method (directly or via distributor): distributor.If it is a distributor ¿ who is it? mckesson.Called the customer today to follow up.She stated that they investigated the incident a little further and provided the updated information below.She also stated that 3 out of the 8 test results were confirmed by pcr but they will not be conducting any re-tests on the other 5 patients.The box of the expired kits were already discarded so she doesn't have the kit lot number available but she is waiting to hear from their distributor if they have it in their records.I will follow up with the customer in a couple of days for the kit lot number.Quantity received and quantity affected: 8 out of 30.If consumable is tested on bd instrumentation, list serial numbers: (b)(6).

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11686426
• MDR Text Key: 246100190
• Report Number: 1119779-2021-00675
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• 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