MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-05-24 for 1/4" X 6' SUCTION TUBING 0037860 manufactured by Conmed Corporation.
[75857960]
As of this filing, the devices have not been returned to conmed for evaluation. Once received and evaluation complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[75857961]
The distributor in (b)(4) reported that during receiving and inspection of incoming products, three (3) packages, containing one each 1/4" x 6' suction tubing, were discovered with "insufficient heat seal. " in this instance, there was no patient involvement with this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.
Patient Sequence No: 1, Text Type: D, B5
[96240367]
Manufacturing date was 2016-07-06.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007305485-2017-00122 |
| MDR Report Key | 6587891 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-05-24 |
| Date of Report | 2017-07-20 |
| Date Mfgr Received | 2017-06-09 |
| Device Manufacturer Date | 2016-07-06 |
| Date Added to Maude | 2017-05-24 |
| 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. LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, CP 1136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 1136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1/4" X 6' SUCTION TUBING |
| Generic Name | SUCTION TUBING |
| Product Code | BYY |
| Date Received | 2017-05-24 |
| Returned To Mfg | 2017-06-06 |
| Catalog Number | 0037860 |
| Lot Number | 201607064 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-24 |