MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-11-28 for 1MM MICROBIOLOGY BRUSH 130 manufactured by Conmed Corporation.
[93168132]
The device was discarded by the user facility therefore unable to be returned and evaluated. The reported failure could not be verified and a root cause cannot be determined. A review of the manufacturing documents could not be performed since the lot number was not provided for this complaint. A two-year review of complaint history revealed this incident to be the only complaint for this product family and failure mode. During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent. A risk analysis was performed and found this failure mode and occurrence level to be acceptable and consistent with current risk documents. The instructions for use advise the user of the following. Severe angulation of the bronchoscope, once the catheter has been fully introduced into the working channel of the scope, may inhibit the wax plug from being expelled and the microbiology brush from being advanced. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[93168133]
The conmed representative reported on behalf of the user facility that during a bronchoscopy for a critically ill patient, the 130 microbiology brush was used to gather a sample. After gathering the sample, the brush was stuck and would not pull back into its sleeve. The physician had to pull out the brush with a moderate move. The patient respiratory status decompensated and an ultrasound and x-rays were performed which showed a pneumothorax. The patient required thoracic drainage. Upon gathering additional information, it was reported that due to this incident the patient required 2 additional days in the intensive care unit. The patient passed away, however, it was reported that this occurred due to the patient being critically ill. This report is raised based on a reported patient serious injury.
Patient Sequence No: 1, Text Type: D, B5
[115016784]
The lot number was provided on 30-jan-2018. A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture. A lot history review was conducted and this is the only complaint for this lot number and failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007305485-2017-00261 |
| MDR Report Key | 7065951 |
| Report Source | OTHER |
| Date Received | 2017-11-28 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2018-01-30 |
| Device Manufacturer Date | 2015-08-20 |
| Date Added to Maude | 2017-11-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 1MM MICROBIOLOGY BRUSH |
| Generic Name | PULMONARY MICROBIOLOGY BRUSHES |
| Product Code | BTG |
| Date Received | 2017-11-28 |
| Catalog Number | 130 |
| Lot Number | 201508204 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2017-11-28 |