MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM; SARS-COV-2 REAGENT KIT

Catalog Number 444213

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Eua# (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the pouch is labeled for n2 but the snap ins have orange foil instead of red with a biogx sars-cov-2 open system reagents for bd max¿ system.Eua# (b)(4).

Manufacturer Narrative

Investigation: the complaint investigation for incorrect labelled master mix pouches in the biogx sars-cov-2 osr assay (ref #(b)(4)) kit lot k21-020 was performed by biogx, product manufacturer.The investigation was performed by the review of the manufacturing records, review of customer¿s picture and by the complaint¿s history review.Customer reported that n1 and n2 master mix pouches had orange foil tubes.The master mix tubes are color-coded: n1 tubes use orange foil seals and n2 tubes use red foil seals.Biogx confirmed that master mix pouches externally labeled as containing n2 tubes were containing n1 tubes.Biogx review of the manufacturing records indicated that some kits of lot k21-020 were affected by the issue.A change of packaging site has contributed to a human error during the labelling process of master mix pouches.Biogx confirm the complaint based on the review of manufacturing record and the picture provided.There is an indication of an increase in complaints for incorrect labelling in the biogx sars-cov-2 osr product.The root cause of the customer issue was a human error during labelling process.Biogx product manufacturer has initiated a preventive and corrective action plan.Bd has also initiated capa#(b)(4).

Event Description

It was reported that the pouch is labeled for n2 but the snap ins have orange foil instead of red with a biogx sars-cov-2 open system reagents for bd max¿ system.Eua# (b)(4).

• Brand Name: BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
• Type of Device: SARS-COV-2 REAGENT KIT
• 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: 11298022
• MDR Text Key: 242061222
• Report Number: 1119779-2021-00271
• Device Sequence Number: 1
• Product Code: QJR
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/30/2021
• Device Catalogue Number: 444213
• Device Lot Number: K21-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• 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