MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-26 for HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGA 1059 manufactured by Teleflex Medical.
[37019280]
(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. No photo for review. A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided. A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident. Customer complaint cannot be confirmed based only on the information reported. If the device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[37019281]
The customer alleges that the joint of the mask and tube came off easily.
Patient Sequence No: 1, Text Type: D, B5
[40497697]
(b)(4). One unit of catalog number 1059 (mask , non-rebreath w/safety vent , elongate) was received for analysis. A visual exam was performed and was it was found that the tube was disconnected from the mask. No residues of pip were found on female adaptor tubing. The device history record (dhr) of lot number 74b1503408 was reviewed and no issues or discrepancies were found that could relate to the reported complaint. No non-conformance reports were originated for the lot in question that can be associated to the complaint reported. The dhr shows that the product was assembled and inspected according to specifications. Based on the investigation performed, the reported complaint was confirmed. The female adaptor tubing and the star lumen frosted tubing were detached and no residues of pip were found on the female adaptor tubing. The manufacturing process was reviewed and no similar issues were found related with the sample received, therefore, this is considered to be an isolated event. As a corrective action , personnel from production were notified about this complaint and will be re-trained on the work instruction.
Patient Sequence No: 1, Text Type: N, H10
[40497698]
The customer alleges that the joint of the mask and tube came off easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00089 |
| MDR Report Key | 5390965 |
| Date Received | 2016-01-26 |
| Date of Report | 2016-01-12 |
| Date of Event | 2015-12-25 |
| Date Mfgr Received | 2016-03-14 |
| Device Manufacturer Date | 2015-02-25 |
| Date Added to Maude | 2016-01-26 |
| 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,NON-REBREATH W/SAFETY VENT,ELONGA |
| Generic Name | MASK,OYGEN - NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-01-26 |
| Returned To Mfg | 2016-02-12 |
| Catalog Number | 1059 |
| Lot Number | 74B1503408 |
| 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 | 2016-01-26 |