MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-27 for HUDSON TUBING, OXYGEN SUPPLY 7' 1115 manufactured by Teleflex Medical.
[103684448]
(b)(4). Visual inspection of the product involved in the complaint was performed on two pictures provided by the customer. Some marks on the tube were observed, however, no issues can be observed that can lead this customer complaint. In order to perform a proper and thorough investigation to confirm the alleged defect reported and determine a root cause, it is necessary to evaluate the sample involved in this complaint. The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. The dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. If the sample becomes available this investigation will be updated with the evaluation results. Teleflex will continue to monitor and trend for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
[103684449]
Customer complaint alleges "tubing kinks where it comes off the wall and collapses making it useless to deliver o2 to patient. " alleged defect reported as detected during use. There was no report of patient impact or consequence. Customer submitted photos with the complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00087 |
| MDR Report Key | 7374574 |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2017-12-06 |
| Date Added to Maude | 2018-03-27 |
| 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 |
| 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 | 0 |
| Brand Name | HUDSON TUBING, OXYGEN SUPPLY 7' |
| Generic Name | TUBING, PRESSURE AND ACCESSORI |
| Product Code | BYX |
| Date Received | 2018-03-27 |
| Returned To Mfg | 2018-05-07 |
| Catalog Number | 1115 |
| Lot Number | 74M1700956 |
| 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 | 2018-03-27 |