MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MOLECULAR SWAB COLLECTION KIT

Catalog Number 443925

Device Problem Break (1069)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: the complaint investigation for broken swab issue when using the bd molecular swab collection kit 100ea (ref #443925) unknown lot number was performed by the review of the manufacturing records, retain material testing and the verification of complaints history.Customer complained about two swabs from lot 9162 which broke off inside a patient during a vaginal swab self-collection, at two different collection sites.Despite multiple attempts made to receive information from the customer, the bd molecular swab collection kit lot used and indication about which area of the swab broke off were not provided for investigation.Since no bd molecular swab collection kit lot number was provided, all the kit lots containing the molecular swab lot 9162 were reviewed.Review of the manufacturing records of bd molecular swab collection kit lots containing the polyester swabs from lot 9162 shows the kits (swabs and sbt tube) were packaged using an automated process.During manufacturing, an issue was observed during the visual inspection.Four swabs from lot 9162 were found to have their shaft come out of the cap (cap being broken).The swab supplier was informed, and the defect has been addressed.Considering that the issue had low occurrence (0.003%) and was detected during the inspection process, all bd molecular swab collection kit lots containing this swab were released.The retain material of bd molecular collection kit from lot 2102669 (containing swab lot 9162) was visually inspected.No anomaly was observed, no broken cap was found and none of the swabs broke upon testing.Based on the investigation and information provided, bd was unable to confirm the exact cause of the customer¿s broken swab issues.However, a defect (broken cap) was observed during the bd molecular swab collection kit manufacturing process at bd quebec, found to be linked to a swab supplier manufacturing issue.This could lead to a customer complaining about a broken swab.However, the breakage would end-up with having a loose cap around the shaft and not a shaft breaking in two during collection.The investigation suggests that the issue is isolated.There is no indication of broken 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 bd molecular swab collection kit vaginal swab broke of during a patient.No injuries were reported.The following information was provided by the initial reporter: vaginal swab breaking off during collection.

Manufacturer Narrative

H6.Investigation summary: the complaint investigation for broken swab issue when using the bd molecular swab collection kit 100ea (ref #443925) unknown lot number was performed by the review of the manufacturing records, retain material testing and the verification of complaints history.Customer complained about two swabs from lot 9162 which broke off inside a patient during a vaginal swab self-collection, at two different collection sites.Despite multiple attempts made to receive information from the customer, the bd molecular swab collection kit lot used and indication about which area of the swab broke off were not provided for investigation.Since no bd molecular swab collection kit lot number was provided, all the kit lots containing the molecular swab lot 9162 were reviewed.Review of the manufacturing records of bd molecular swab collection kit lots containing the polyester swabs from lot 9162 shows the kits (swabs and sbt tube) were packaged using an automated process.During manufacturing, an issue was observed during the visual inspection.Four swabs from lot 9162 were found to have their shaft come out of the cap (cap being broken).The swab supplier was informed, and the defect has been addressed.Considering that the issue had low occurrence (0.003%) and was detected during the inspection process, all bd molecular swab collection kit lots containing this swab were released.The retain material of bd molecular collection kit from lot 2102669 (containing swab lot 9162) was visually inspected.No anomaly was observed, no broken cap was found and none of the swabs broke upon testing.Based on the investigation and information provided, bd was unable to confirm the exact cause of the customer¿s broken swab issues.However, a defect (broken cap) was observed during the bd molecular swab collection kit manufacturing process at bd quebec, found to be linked to a swab supplier manufacturing issue.This could lead to a customer complaining about a broken swab.However, the breakage would end-up with having a loose cap around the shaft and not a shaft breaking in two during collection.The investigation suggests that the issue is isolated.There is no indication of broken 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 bd molecular swab collection kit vaginal swab broke of during a patient.No injuries were reported.The following information was provided by the initial reporter: vaginal swab breaking off during collection.

• Brand Name: BD MOLECULAR SWAB COLLECTION KIT
• Type of Device: NA
• 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 ; 8448235433
• MDR Report Key: 16440405
• MDR Text Key: 310353700
• Report Number: 1119779-2023-00169
• 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: 03/06/2023

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: 9162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1