MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-04-05 for HUDSON MASK KIT,FIXED VENTURI,ADULT,INTL 41098 manufactured by Teleflex Medical.
[104569462]
(b)(4). Inspection of the product involved in the complaint could not be conducted since the product or a picture of the alleged defect was not provided at the time of this report. It is unclear if the device is available for investigation. Teleflex has requested this information. 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 reported, determine the root cause and establish any corresponding corrective actions, it is necessary to evaluate the sample involved in this complaint. Customer complaint cannot be confirmed based only on the information provided. Root cause is unknown. No corrective actions can be established. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[104569463]
Customer complaint alleges that individual items have no lot numbers or flow rates identified on the plain unit packaging although these details are provided on the box quantity?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00107 |
| MDR Report Key | 7400223 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-04-05 |
| 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 MASK KIT,FIXED VENTURI,ADULT,INTL |
| Generic Name | MASK,OXYGEN,LOW CONCENTRATION,VENTUR |
| Product Code | BYF |
| Date Received | 2018-04-05 |
| Catalog Number | 41098 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |