MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-10-29 for 1/4"(6.4MM)X6'(1.8M) W/M&F CO 0037860 manufactured by Consolidated Medical Equipment.
[126536501]
One (1) (b)(4) was received in original, unopened packaging. The reported catalog and lot numbers were verified. Visual inspection of the device found no obvious abnormalities with regards to the seal of the device however, the poly component of the packaging was stressed at the location in which the white tip of the device meets the packaging. Dye testing was conducted on the device and found that there was no breach of sterility in the seal of the packaging. However, a hole was identified at the location of the stressed poly where ink was able to drip out of the packaging. The hole in the poly component of the packaging compromises the sterility of the device. 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 9 complaints, regarding 10 devices, for this device family and failure mode. During this same time frame 2,466,900 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 (b)(4). 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
[126536502]
During incoming inspection, the distributor rejected this device, (b)(4),? "x6' w/m&f co (surgical tubing) lot 201708084 for a tear in the sterile pouch/blister pack. There was no contact with the patient as this was found during incoming inspection. Due to the breach in sterility, this complaint meets the criteria for a reportable event. This report is being raised as a malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00229 |
| MDR Report Key | 8016614 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2017-08-08 |
| Date Added to Maude | 2018-10-29 |
| 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 | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal | 337734908 |
| Manufacturer Phone | 7273995557 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, MEXICO 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 | 2018-10-29 |
| Returned To Mfg | 2018-09-21 |
| 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, MEXICO 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |