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

Catalog Number 44500301

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that mold was discovered in a bd sars-cov-2 reagents for bd max¿ system.(b)(4).The following information was provided by the initial reporter: bd sars cov-2 assay kit (445003-01) lot number 1228397 reported to have mold near the buffer tubes located in the unitised reagent strips.

Manufacturer Narrative

H.6.Investigation: the complaint investigation for cosmetic issue on the bd max sars-cov-2 reagents kit (ref #(b)(4)) lot 1228397 was performed by the review of the manufacturing records, retain material inspection, review of customer¿s pictures and by the complaint¿s history review.Review of the manufacturing records of bd max sars-cov-2 reagent indicated that the unitized reagent strip (urs) contained in the kit were manufactured using automated production process and the lot was manufactured according to specifications and met performance requirements.The retain material of bd max sars-cov-2 from lot 1228397 was inspected and all strips were conforming.No anomaly was observed.Pictures were received from the customer for the investigation.Pictures showed black matter around the foil of the buffer wells of 6 consecutive urs.It was confirmed through discussion with the manufacturing engineering team that black matter was indeed burnt trails from the laser beam used to cut the wells' sealing foil.These marks are consistent with observations that were previously observed when the machine has been stopped.The laser is cutting the foil on 6 consecutive urs explaining why only 6 strips are found with those burnt marks.These burnt marks have been assessed and were found to have no impact on product performance nor on the strip's foil seal integrity.There is no indication of a trend for this defect based on the analysis of the complaints received on the bd max sars-cov-2 reagent kit lot 1228397.The root cause was identified as laser burnt mark having no impact on product performance.Bd confirms the complaint for a cosmetic defect based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since the issue is isolated and has only a cosmetic impact on the product.Bd quality will continue to monitor for trends.

Event Description

It was reported that mold was discovered in a bd sars-cov-2 reagents for bd max¿ system.Eua#: (b)(4).The following information was provided by the initial reporter: bd sars cov-2 assay kit (445003-01) lot number 1228397 reported to have mold near the buffer tubes located in the unitised reagent strips.

• Brand Name: BD SARS-COV-2 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13285043
• MDR Text Key: 292034643
• Report Number: 1119779-2021-02170
• Device Sequence Number: 1
• Product Code: QJR
• 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: 03/17/2022

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: 03/18/2022
• Device Catalogue Number: 44500301
• Device Lot Number: 1228397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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