MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 1MM MICROBIOLOGY BRUSH; PULMONARY MICROBIOLOGY BRUSHES

Catalog Number	130
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: 1MM MICROBIOLOGY BRUSH
• Common Device Name: PULMONARY MICROBIOLOGY BRUSHES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• MDR Report Key: 7434372
• Report Number: 3007305485-2018-00046
• Device Sequence Number: 11097799
• Product Code: BTG
• UDI-Device Identifier: 00653405052343
• UDI-Public: (01)00653405052343(17)220926(30)1(10)201709274
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K820771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/26/2022
• Device Catalogue Number: 130
• Device Lot Number: 201709274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR