MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MOLECULAR SWAB COLLECTION KIT; UNKNOWN

Catalog Number 443925

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd molecular swab collection kit liquid comes out from the top of the tube cap using the single-tube "hand" vortex.Customer also stated that this was a previously pierced tube that is supposed to be able to be revortexed and retested without replacing the cap.No patient impact reported.The following information was provided by the initial reporter: customer reported that liquid comes out from the top of the tube cap using the single-tube "hand" vortex.Customer also informed that this was a previously pierced tube that is supposed to be able to be revortexed and retested without replacing cap.

Manufacturer Narrative

This complaint is not reportable.There was no splashing so it should be reagent leakage (contained within instrument).Cancel mfr report.

Event Description

It was reported that while using bd molecular swab collection kit liquid comes out from the top of the tube cap using the single-tube "hand" vortex.Customer also stated that this was a previously pierced tube that is supposed to be able to be revortexed and retested without replacing the cap.No patient impact reported.The following information was provided by the initial reporter: customer reported that liquid comes out from the top of the tube cap using the single-tube "hand" vortex.Customer also informed that this was a previously pierced tube that is supposed to be able to be revortexed and retested without replacing cap.

• Brand Name: BD MOLECULAR SWAB COLLECTION KIT
• Type of Device: UNKNOWN
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15539572
• MDR Text Key: 306336077
• Report Number: 3007420875-2022-00059
• Device Sequence Number: 1
• Product Code: OUY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182692
• 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: 10/14/2022

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: 02/25/2023
• Device Catalogue Number: 443925
• Device Lot Number: 2014374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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