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

Catalog Number 443925

Device Problem Break (1069)

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

Event Date 11/30/2022

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 bd molecular swab collection kit swabs are not broken properly and stick out of the tube.The following information was provided by the initial reporter: customer reports receiving 3 ct/gc/tv2 vaginal collection swabs that are not properly broken at the score mark; swab sticking out of tube.Hazard, injury or erroneous results? no.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for fit issue with the swab when using the bd molecular swab collection kit 100ea (ref #443925) unknown lot number was performed by the verification of complaints history.No kit lot number or picture was provided for investigation, which was thus limited.However, in a previous investigation, it was determined that off-label use of the swab could lead to issues such as those described by the customer.Indeed, when the swab¿s score mark is aligned with the edge of the tube, it breaks easily at the black line which is what is expected.However, when the swab is fully inserted into the tube, it can break above the black score mark resulting in the swab sticking out of the tube.As documented in the bd molecular swab collection kit package insert p0246, the swab must not be inserted at the bottom of the sample buffer tube but must be inserted so that the score mark indicated by the black line is at the lip of the tube.The swab shaft must be broken at the score mark so that the swab drops into the tube.In comparison, review of the bd max¿ uve specimen collection kit (443376) which is the collection kit previously used by the customer with the bd max¿ vaginal panel or the bd max¿ ctgctv assays, revealed that this other collection kit used a different swab which needed to be fully inserted into the sbt before breakage.This differs from the bd molecular swab collection kit procedure and could make the shaft breakage difficult, thus explain the issue.Based on the results of this investigation, the cause of the issue is suspected to be an improperly broken shaft due to an improper technique used for shaft breakage.There is no indication of defective swab issue based on the analysis of the complaints received on bd molecular swab collection kit 100ea product.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.H3 other text : see h.10.

Event Description

It was reported that bd molecular swab collection kit swabs are not broken properly and stick out of the tube.The following information was provided by the initial reporter: customer reports receiving 3 ct/gc/tv2 vaginal collection swabs that are not properly broken at the score mark; swab sticking out of tube.Hazard, injury or erroneous results? no.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3007420875-2022-00079 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

• Brand Name: BD MOLECULAR SWAB COLLECTION KIT
• Type of Device: NA
• 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: 15969179
• MDR Text Key: 308091318
• Report Number: 3007420875-2022-00079
• 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,Followup
• Report Date: 05/09/2023

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: 443925
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 01/24/2023; 05/08/2023
• Supplement Dates FDA Received: 01/27/2023; 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1