MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-01-29 for HUDSON DUAL HEATED DUAL DRAIN 880-36KIT manufactured by Teleflex Medical.
[5404215]
The customer alleges that the concha column was leaking. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[12909913]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. Device history record (dhr) investigation of batch number (b)(4) did not show issues related to complaint. No nonconformity reports originated for lot in question that can be associated to the complaint reported. The product was assembled and inspected according to specifications. No corrective action can be established since the device sample or a picture of it is not available for eval. Customer complaint cannot be confirmed due to the lack of product sample or picture. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is it being manufactured at the time. If the physical sample becomes available this complaint will be reopened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00052 |
| MDR Report Key | 4474996 |
| Report Source | 05,06,07 |
| Date Received | 2015-01-29 |
| Date of Report | 2015-01-08 |
| Date of Event | 2015-01-06 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN, RA |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON DUAL HEATED DUAL DRAIN |
| Product Code | CAG |
| Date Received | 2015-01-29 |
| Catalog Number | 880-36KIT |
| Lot Number | 74K1402731 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-29 |