MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-10-23 for 1/4"(6.4MM)X6'(1.8M) W/M&F CO 0037860 manufactured by Consolidated Medical Equipment.
[126113301]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[126113302]
During incoming inspection, the distributor rejected item (b)(4), 1/4" (6. 4mm) x 6' w/m&f surgical tubing for an insufficient heatseal. There was no contact with the patient as this was found during incoming inspection. Due to the potential severity of a breach in sterility, this complaint meets the criteria for a reportable event. This will be reported as a malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00235 |
| MDR Report Key | 7995116 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-10-23 |
| Date of Report | 2018-11-14 |
| Date Mfgr Received | 2018-10-26 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-10-23 |
| 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 | 2018-10-23 |
| Returned To Mfg | 2018-10-26 |
| Catalog Number | 0037860 |
| Lot Number | 201709275 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-10-23 |