MAUDE Adverse Event Report: BECTON, DICKINSON CARIBE LTD. AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS

Catalog Number 446252

Device Problems Break (1069); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 12/02/2011

Event Type  Injury  

Event Description

Bd was informed of an incident associated with the use of the bd affirm vpiii microbial identification test kit.In an attempt to collect a vaginal sample, the patient mistakenly inserted the affirm swab into her urethra.The swab tip broke off (as it is intended to do when placed in the testing vial) and became lodged in her bladder.Following an ultrasound, an endoscope was used to remove the swab tip from the patient's bladder.The lab, (b)(6), stated it is their policy to have the patient self-collect a vaginal sample.The patient is provided with a swab from the test kit and the following instructions to self-collect in the bathroom on-site: "insert the swab into the vagina as far as you comfortably can as you would insert a tampon".Lab: (b)(6).

Manufacturer Narrative

Bd molecular quality initiated an investigation into this customer report regarding the bd affirm vp iii microbial identification test (bd affirm).The bd affirm vpiii microbial identification test kit is intended for vaginal sample collection and is not labeled for self-collection.In addition, complaint history review revealed no customer complaints related to unintended affirm swab breakage.Complaint history encompasses fifteen years of data over several million affirm swabs/tests.Bd will continue, as always, to monitor complaints related to use of the bd affirm vpiii microbial identification test.However, based on the investigation and complaint history, this is considered to be an isolated event.

• Brand Name: AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS
• Manufacturer (Section D): BECTON, DICKINSON CARIBE LTD.; cayey PR
• Manufacturer (Section G): BECTON, DICKINSON CARIBE LTD.; vicks drive lot# 6; cayey PR 00737
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton circle; sparks, MD 21152 ; 4103164367
• MDR Report Key: 3621492
• MDR Text Key: 4131594
• Report Number: 1119779-2014-00006
• Device Sequence Number: 1
• Product Code: MLA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 446252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention