MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-06-22 for HUDSON OXYGEN SUPPLY TUBING CONNECTOR 1420 manufactured by Teleflex Medical.
[112196725]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted , since the device was not received yet at our facility, and no pictures have been received for evaluation of the alleged defect reported. A device history record review could not be conducted since the lot number was not provided. To perform a proper and thorough investigation to confirm the alleged defect and determine the root cause, it is necessary to evaluate the sample involved. Customer complaint cannot be confirmed based on the information received. Root cause is unknown. No corrective actions can be assigned at this time. If the device sample becomes available at a later date this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[112196726]
Customer complaint alleges the device easily disconnects. Alleged issue reported occurred during patient use. No patient injury or consequence was reported. The patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00207 |
| MDR Report Key | 7630399 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-06-12 |
| Date Added to Maude | 2018-06-22 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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 OXYGEN SUPPLY TUBING CONNECTOR |
| Generic Name | TUBING, PRESSURE AND ACCESSORI |
| Product Code | BYX |
| Date Received | 2018-06-22 |
| Catalog Number | 1420 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |