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

Medical device expiration date: unknown.Device manufacture date: unknown.Initial reporter e-mail:(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd molecular swab collection kit that there was a swab tip or shaft break.Max 443925 vaginal collection swab issue.

Manufacturer Narrative

H.6 investigation summary the complaint investigation for broken swab when using the bd molecular swab collection kit 100ea (ref #443925) unknown lot number was performed by the verification of complaints history.Customer complained about a swab from unknown lot which broke off during a vaginal swab self-collection, at a collection site.Despite multiple attempts made to receive information from the customer, no lot information was received nor any indication about which area of the swab broke off were not provided for investigation.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.Bd did not initiate a corrective and preventive action since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.H3 other text : see h.10.

Event Description

It was reported that while using the bd molecular swab collection kit that there was a swab tip or shaft break.Max 443925 vaginal collection swab issue.

• 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: 16475448
• MDR Text Key: 310594649
• Report Number: 1119779-2023-00201
• 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
• Report Date: 04/21/2023

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: 02/03/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/01/2023
• 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