MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX SARS-COV-2 REAGENTS KIT; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 44500301

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while testing with bd max sars-cov-2 reagents kit one kit had the incorrect part mixed in with it.There was no report of patient impact.The following information was provided by the initial reporter: bd sars cov-2 445003-01 kit came with a wrong exk reagent/snap in.1 pouch is exk dna lot # 1319143 instead of exk tna.Quantity received and quantity affected: 1 bd sars cov-2 445003-01 kit.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for mix of extraction tubes pouches between two consecutives kits lots in the bd sars cov-2 reagents for max¿ system (ref #44500301) kit from lot 1299962 was performed by the review of manufacturing records, retention material inspection, review of customer¿s picture review and verification of complaints history.Customer reported receiving one bd sars cov-2 reagents for max¿ system kit from lot 1299962 which contained a pouch of dna extraction tubes (tx) instead of a pouch of tna extraction tubes.Review of the manufacturing process revealed that the bd sars cov-2 reagents kit lot 1299962 was produced using the fully automated process.The lot produced just before corresponds to a bd max¿ exk¿ dna kit lot 1306434, including tx from lot 1319143, also found by the customer.The retain material of bd sars cov-2 reagents from lot 1299962 was visually inspected and no anomaly was observed.The picture, provided by customer shows a bd max¿ exk¿ dna extraction tubes pouch from lot 1319143.The most likely hypothesis to explain the customer issue is an incomplete line clearance between the end of production of the bd max¿ exk¿ dna kit and the start of the bd sars cov-2 reagents for bd max¿ systems kit lot 1299962.There is no indication of mix of extraction tubes pouches between two consecutive kits based on the analysis of the complaints received on bd max products.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.No corrective and preventive action (capa) was initiated at this time but improvements to the line clearance process were since made, implemented, and communicated to the operators.These improvements were made after manufacturing of bd sars cov-2 reagents for max¿ system kit lot 1299962.

Event Description

It was reported while testing with bd max sars-cov-2 reagents kit one kit had the incorrect part mixed in with it.There was no report of patient impact.The following information was provided by the initial reporter: bd sars cov-2 445003-01 kit came with a wrong exk reagent/snap in.1 pouch is exk dna lot # 1319143 instead of exk tna.Quantity received and quantity affected: 1 bd sars cov-2 445003-01 kit.

• Brand Name: BD MAX SARS-COV-2 REAGENTS KIT
• 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: 13722199
• MDR Text Key: 286945137
• Report Number: 1119779-2022-00410
• 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: 03/18/2022

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: 05/27/2022
• Device Catalogue Number: 44500301
• Device Lot Number: 1299962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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