MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT FLOVAC LAP S/I W/5MM CANNULA; SUCTION IRRIGATION

Catalog Number	60-6005-505
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported unused device was returned for evaluation in its original unopened package.Label verification and visual inspection were performed.The product's inner and outer packaging revealed damaged caused by the device, which created a breach in sterility.This damage is most likely due to excessive force applied to the device after the sealing process occurred.This "damage" does not appear to be manufacturing related.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.Of the lot containing 250 units, no prior complaints have been received.A two-year review of complaint history revealed two similar prior complaints.During this same time frame, 32,460 devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure 0.009 percent.This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.The instructions for use (ifu) provides the following warning.If packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor in (b)(6) reported "damage" on the sterile pouch of the device.There was no patient involvement as this defect was discovered during incoming inspection.This report is raised on the basis of a sterility breach found during the device evaluation.

• Brand Name: FLOVAC LAP S/I W/5MM CANNULA
• Common Device Name: SUCTION IRRIGATION
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• MDR Report Key: 7296190
• Report Number: 3007305485-2018-00043
• Device Sequence Number: 16606111
• Product Code: GCJ
• UDI-Device Identifier: 00653405034752
• UDI-Public: (01)00653405034752(17)190218(30)1(10)201602194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K940439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/18/2019
• Device Catalogue Number: 60-6005-505
• Device Lot Number: 201602194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1