MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-20 for 1/4"(6.4MM)X6'(1.8M) W/M&F CO 0037860 manufactured by Consolidated Medical Equipment.
[111716151]
One device was received in unopened, original packaging. The reported catalog number and lot number were verified. Inspection of the device found that a breach was in the seal area. Due to the location and shape of the breach, it is likely that the device pushed from inside of the packaging and breached the seal. The breach was caused from the inside out. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution were found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the past two years. A two-year review of complaint history revealed there has been a total of 40 complaints, regarding 76 devices, for this device family and failure mode. During this same time frame 15,355,050 devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0. 000005. It is standard medical practice to inspect all device prior to use. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[111716152]
The distributor in (b)(6) rejected one 0037860, 1/4"(6. 4mm)x6"(1. 8m) w/m&f co, device due to an "insufficient heatseal". In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user. The report is raised on the basis of a device malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00148 |
| MDR Report Key | 7620306 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-20 |
| Date Mfgr Received | 2018-05-24 |
| Device Manufacturer Date | 2017-08-08 |
| Date Added to Maude | 2018-06-20 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1/4"(6.4MM)X6'(1.8M) W/M&F CO |
| Generic Name | TUBE, ASPIRATING, FLEXIBLE, CONNECTING |
| Product Code | BYY |
| Date Received | 2018-06-20 |
| Returned To Mfg | 2018-06-11 |
| Model Number | 0037860 |
| Catalog Number | 0037860 |
| Lot Number | 201708084 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |