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 Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Eua# (b)(4).Medical device lot #: there were multiple lot numbers reported to be involved 020-335-1065 & 020-335-1066, however, these are not lot #'s manufactured for this product.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.(b)(4).

Event Description

It was reported that while using biogx sars-cov-2 open system reagents for bd max¿ system 9 vials were discovered to be leaking.Customer reported lot # 020-335-1065 had 6 vials that were low or no buffer at all.There were 3 vials with lot# 020-335-1066 that were low.Eua# (b)(4).

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00258 was sent in error.Physical defect - broken is not considered to be a reportable malfunction.

Event Description

It was reported that while using biogx sars-cov-2 open system reagents for bd max¿ system 9 vials were discovered to be leaking.Customer reported lot # 020-335-1065 had 6 vials that were low or no buffer at all.There were 3 vials with lot# 020-335-1066 that were low.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: 11288589
• MDR Text Key: 242060353
• Report Number: 1119779-2021-00258
• 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 Catalogue Number: 444213
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 02/09/2021
• 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