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 11/23/2022

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 the bd molecular swab collection kit swab was hard to break off at the mark.No injuries occurred.The following information was provided by the initial reporter: customer reporting that the swab was sticking out of the tube due to the fact that the swab was hard to break-off at the designated score mark, catalog# 443925, lot# 2102669.

Event Description

It was reported that bd molecular swab collection kit swab was hard to break off at the mark no injuries occurred.The following information was provided by the initial reporter: customer reporting that the swab was sticking out of the tube due to the fact that the swab was hard to break-off at the designated score mark, catalog# 443925, lot# 2102669.

Manufacturer Narrative

H.6 investigation summary : (b)(4).The customer complained about a fit issue when using the bd molecular swab collection kit from lot 2102669.According to the customer, the swab was sticking out of the tube due to the fact that the swab was hard to break-off at the designated score mark.Complaint history review revealed that no other complaint was received for the bd molecular swab collection kit lot 2102669.In the last twelve months, six other complaints were opened for a fit issue, on different components and various assays but no other about the bd molecular swab collection kit.Nonetheless, review of the complaint history also showed that 3 complaints opened on the bd molecular swab collection kit for leaking or damage issues and all concerned a problem with breaking of the swab into the sbt, similar to the description of the current complaint, and were caused by a user issue.Based on the review, no reagents issue is suspected.No anomaly was observed in bhr review of the bd molecular swab collection kit lot 2102669 which could have a link with the customer issue.The kit met release specifications.Twelve samples of the retain sbt tubes and polyester swabs included in the bd molecular swab collection kit lot 2102669 were visually inspected and no anomaly was observed.Moreover, the swabs were broken in the sbt to verify breakage at the mark line, using 2 conditions; six were fully inserted at the bottom of the tube and six were inserted until the score mark was at the lip of the tube, and the swabs were then broken.The swab shaft easily broke at the black mark line, as expected, for the six tubes inserted until the lip of the tube.However, for the swabs that were fully inserted at the bottom of the tube, the shaft of 5 out of the six swabs broke above the black score mark and the shaft is exceeding the tube.The retain material analysis showed no anomaly and the shaft broke as expected, if used as described in the bd molecular swab collection kit package insert.No sample was received for investigation.Two pictures were received for the investigation.One shows a pierced sample buffer tube from a bd molecular swab collection kit with a swab that is exceeding the tube, and the other shows multiple pierced sample buffer tubes with one swab shaft exceeding a tube.Also, this shaft is cut well above the black line score mark.As documented in the bd molecular swab collection kit package insert p0246, the swab must be inserted so that the score mark indicated by the black line is at the lip of the tube and 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, 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.Use of the former breakage procedure could make the shaft breakage difficult, explaining the customer issue.Based on the results of this investigation, the cause of the issue is suspected to be an improperly broken shaft, due to off label use.However, although bd is unable to confirm this hypothesis, based on the investigation, no reagent issue is suspected.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3007420875-2022-00081 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.

Event Description

It was reported that bd molecular swab collection kit swab was hard to break off at the mark no injuries occurred.The following information was provided by the initial reporter: customer reporting that the swab was sticking out of the tube due to the fact that the swab was hard to break-off at the designated score mark, catalog# 443925, lot# 2102669.

• 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: 15995304
• MDR Text Key: 307184659
• Report Number: 3007420875-2022-00081
• 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: 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 Expiration Date: 04/29/2023
• Device Catalogue Number: 443925
• Device Lot Number: 2102669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/04/2023; 05/08/2023
• Supplement Dates FDA Received: 01/11/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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