MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-04-16 for 1MM MICROBIOLOGY BRUSH 130 manufactured by Consolidated Medical Equipment Company.
[105606084]
Corrected data- (b)(4). The used device was returned to conmed with original opened product packaging. Upon visual inspection, the device was noted to have two detached wire pieces. The device's thumb-ring guidewire was observed to be bent. Due to the condition of the received complaint device, the detachment point of the reported defect could not be evaluated or determined. 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 at the time of manufacture. A two-year review of complaint history revealed no other similar complaints for this product family and failure mode. (b)(4). The clinical data report for this device states that, when used under the conditions and purposes intended by the manufacturer, the undesirable side effects, under normal conditions of use, are acceptable when weighed against the benefits to patients. The instructions for use advises the user of the following. Upon inspection prior to use, do not use if catheter or handles appear to be damaged. Inspect the catheter for any damage which may have occurred in transit. This device must be used only by or under the supervision of physicians trained in diagnostic bronchoscopy techniques. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[105606085]
Conmed received a medwatch report submitted by the user facility. In this report, the user facility stated that post bronchoscopy procedure, the 130 microbiology brush's tip was noticed to be missing. Attempts were made to search for the detached tip on the patient and in the bronchial lavage, but the device's tip was not found. Upon multiple attempts to gather information, the reporter stated that no additional information regarding the patient status or procedure will be made available. The only information provided is the medwatch, which makes no mention/report of any procedural delays or patient injury. This report is raised on the basis of a reported malfunction, due to which, part of the device detached and it's location is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00046 |
| MDR Report Key | 7434372 |
| Report Source | OTHER |
| Date Received | 2018-04-16 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-03-22 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-04-16 |
| 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 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA CP 1136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 1136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1MM MICROBIOLOGY BRUSH |
| Generic Name | PULMONARY MICROBIOLOGY BRUSHES |
| Product Code | BTG |
| Date Received | 2018-04-16 |
| Returned To Mfg | 2018-03-12 |
| Catalog Number | 130 |
| Lot Number | 201709274 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Address | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA CP 1136 MX CP 1136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-16 |