MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD CTGCTV2 FOR BD MAX¿ SYSTEM (US)

Catalog Number 443925

Device Problem Break (1069)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd ctgctv2 for bd max¿ system (us) that there was difficulty breaking the swab.The following information was provided by the initial reporter: customer is reporting swabs are protruding from the sample buffer tubes.Causing the instrument to get out of alignment and ending the run when using 443925, lot 2014374.

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for swabs protruding from sample buffer tubes (sbt) causing the bd max instrument to get out of alignment, when using the bd molecular swab collection kit 100ea (ref #443925) lot 2014374 was performed by the review of the manufacturing records, retain material testing and the verification of complaints history.However, lab personnel tested the product and did not have any problem breaking the swab at the designated score mark.Review of the manufacturing records of sbt lots included in bd molecular swab collection kit lot 2014374 indicated that the sbt lot was manufactured according to specifications and met performance requirements.During manufacturing, the polyester swabs (purchased from another manufacturer) are packed with a sbt tube.No anomaly was observed in manufacturing records that could explain the customer issue.The retain material of sbt tubes and polyester swabs included in bd molecular swab collection kit lot 2014374 was visually inspected and several swabs were broken in the sbt to verify breakage at the mark line.The swab shaft easily broke at the black mark line, as expected.The retain material analysis showed no anomaly and performed as expected.No picture was received for the investigation, however the most probable cause of the collection site issue with swab breakage is the swab shaft not being broken at the proper black score mark against the tube edge.When a swab¿s black score mark is aligned with the edge of the tube, it breaks easily at the designated section, 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 be inserted so that the score mark, indicated by the black line, is at the edge of the tube and broken at the score mark.Use of the improper breakage procedure could potentially explain the customer reported issue (swab protruding from sbt) and is suspected of being the cause of the customer¿s issue.There is no indication of defective swab issue based on the analysis of the complaints received on bd molecular swab collection kit 100ea products.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

Event Description

It was reported that while using the bd ctgctv2 for bd max¿ system (us) that there was difficulty breaking the swab.The following information was provided by the initial reporter: customer is reporting swabs are protruding from the sample buffer tubes.Causing the instrument to get out of alignment and ending the run when using 443925, lot 2014374.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3007420875-2022-00082 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 while using the bd ctgctv2 for bd max¿ system (us) that there was difficulty breaking the swab.The following information was provided by the initial reporter: customer is reporting swabs are protruding from the sample buffer tubes.Causing the instrument to get out of alignment and ending the run when using 443925, lot 2014374.

• Brand Name: BD CTGCTV2 FOR BD MAX¿ SYSTEM (US)
• 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: 16061850
• MDR Text Key: 308352215
• Report Number: 3007420875-2022-00082
• 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: 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: 12/20/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/23/2023; 05/08/2023
• Supplement Dates FDA Received: 01/25/2023; 05/19/2023
• 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