MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-31 for AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS 446252 manufactured by Becton, Dickinson Caribe Ltd..
[4131594]
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).
Patient Sequence No: 1, Text Type: D, B5
[11643379]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00006 |
| MDR Report Key | 3621492 |
| Report Source | 05 |
| Date Received | 2014-01-31 |
| Date of Report | 2013-12-31 |
| Date of Event | 2011-12-02 |
| Date Mfgr Received | 2013-12-31 |
| Date Added to Maude | 2014-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON, DICKINSON CARIBE LTD. |
| Manufacturer Street | VICKS DRIVE LOT# 6 |
| Manufacturer City | CAYEY PR 00737 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS |
| Product Code | MLA |
| Date Received | 2014-01-31 |
| Catalog Number | 446252 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON CARIBE LTD. |
| Manufacturer Address | CAYEY PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-31 |