MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-05-07 for 1/4"(6.4MM)X6'(1.8M) W/M&F CO 0037860 manufactured by Consolidated Medical Equipment.
[107497889]
The reported unused device was returned for evaluation in its original opened package. Label verification and visual inspection were performed. The device's short, straight seal was observed to have a seal area less than 1/4". Adjacent the device's defect area and male connector, the packaging was observed to have a tear. This defect resulted in a breach of sterility. Dye leak testing was performed on the defect seal area. Dye was observed to not penetrate the seal area. The packaging defect seal area was inspected for seal transfer. Seal transfer was observed to be less than 1/4" in the defect area. Due to the location and appearance of the defects, it is likely that the device was in the seal area during the sealing process and therefore a manufacturing related issue. 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 3 complaints, regarding 4 devices, for this device family and failure mode. During this same time frame 15,573,370 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. 0000003. It is standard medical practice to inspect all medical devices 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
[107497890]
The distributor in (b)(6) reported a "tear" on the sterile pouch of this 0037860, surgical tubing. There was no patient involvement as this defect was discovered during incoming inspection. This report is raised on the basis of a malfunction due to a sterility breach found during the device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00098 |
| MDR Report Key | 7490645 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-07 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2018-05-07 |
| 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 | 2018-05-07 |
| Returned To Mfg | 2018-03-30 |
| Model Number | 0037860 |
| Catalog Number | 0037860 |
| Lot Number | 201701035 |
| 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 | 2018-05-07 |