MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2017-10-09 for 3/16" (4.8MM) X 6' (1.8M) 0036480 manufactured by Consolidated Medical Equipment.
[90038142]
The reported device is expected to be returned for evaluation. A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[90038143]
The distributor in (b)(4) rejected a 0036480 3/16" (4. 8mm) x 6' (1. 8m) surgical tubing set with "insufficient heatseal" during incoming inspection. In this instance, there was no patient involvement as the packaging anomaly was discovered 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 | 3007305485-2017-00224 |
| MDR Report Key | 6933051 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2017-10-09 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-11-01 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2017-10-09 |
| 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 | LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3/16" (4.8MM) X 6' (1.8M) |
| Generic Name | SURGICAL TUBING |
| Product Code | BYY |
| Date Received | 2017-10-09 |
| Returned To Mfg | 2017-10-30 |
| Catalog Number | 0036480 |
| Lot Number | 201701314 |
| 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 | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, CHIHUAHUA 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-09 |