MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-12-10 for HUDSON SMOOTH-FLO CORR-A-TUBE,6' 1418 manufactured by Teleflex Medical.
[130034415]
(b)(4). The device involved has not been received for evaluation by the manufacturer at the time of this report. The device history record (dhr) of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. To perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[130034416]
Customer complaint alleges that during functional testing prior to patient use there was a leak detected in the device. No patient involvement was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00350 |
| MDR Report Key | 8146580 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-12-10 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-11-17 |
| Date Mfgr Received | 2019-01-04 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2018-12-10 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON SMOOTH-FLO CORR-A-TUBE,6' |
| Generic Name | SET, TUBING AND SUPPORT, VENTI |
| Product Code | BZO |
| Date Received | 2018-12-10 |
| Returned To Mfg | 2018-12-05 |
| Catalog Number | 1418 |
| Lot Number | 74C1800972 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-10 |