MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-21 for CONMED DISPOSABLE MICROBIOLOGY BRUSH 130 manufactured by Conmed Corporation.
[2632537]
It was reported, "performed a lavage on patient. Cytology brushes were then used and tiny blue pieces appeared in the patient's airway. " it also was reported that no patient injury resulted from the event.
Patient Sequence No: 1, Text Type: D, B5
[9770913]
This is being reported to the fda due to the nature of the complaint: unretrieved device fragments (udf). When the quality engineering evaluation is completed a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[9799567]
The suspect device is a conmed disposable, single-use microbiology brush designed to provide a method of obtaining contamination free specimens, primarily from the lower respiratory tract. It consists of a catheter within a catheter with a centrally located sampling brush. A wax-like plug prevents contamination of the inner catheter and brush before sampling. The plug will dissolve safely after being expelled from the catheter. This device is indicated to extract sterile microbiological specimens of the bronchial tree without contamination from the upper airway or bronchoscope. A review of the manufacturing documents from the dhr/lhr, device history record/lot history record, for lot 1111284 has verified the devices were produced according to current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture. Two (2) used devices were returned to the conmed complaint handling center for investigation. The returned device were examined in the laboratory. Both devices were visually checked for any damage. No scratches or kinks or damage of any kind was observed on each device that could account for any device fragments separating from the device. Both devices were observed as undamaged, and, intact. There was no conclusive evidence of any product damage noticed during the examination that could cause the customer reported complaint failure. This incident occurred when a conmed disposable, single-use microbiology brush was used in conjunction with a fairly new boston scientific endoscope. From conversations with hospital endoscopy staff, it is now believed that the udf's, unretrieved device fragments, are from the boston scientific scope. This stems from the fact that the same "tiny blue pieces" that appeared in the patient's airway have also occurred in numerous other procedures where the boston scientific scope is the common factor. Many of the procedures that the same blue udf's have occurred where a conmed device was never utilized in the procedure, yet, the boston scientific endoscope was utilized. The complaint investigation has not identified nor confirmed any manufacturing defects associated with the returned devices. No corrective action is recommended at this time. Conmed is considering this complaint closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007305485-2012-00020 |
| MDR Report Key | 2498927 |
| Report Source | 06 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-04-16 |
| Date of Event | 2012-02-14 |
| Date Mfgr Received | 2012-02-21 |
| Device Manufacturer Date | 2011-11-28 |
| Date Added to Maude | 2012-03-23 |
| 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 | MR. STEPHEN CASANOVA |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, 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 | CONMED DISPOSABLE MICROBIOLOGY BRUSH |
| Generic Name | MICROBIOLOGY BRUSH |
| Product Code | BTG |
| Date Received | 2012-03-21 |
| Returned To Mfg | 2012-03-02 |
| Catalog Number | 130 |
| Lot Number | 1111284 |
| Device Expiration Date | 2016-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502599 US 13502 5994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-21 |