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 2017-05-24 for HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM 1755 manufactured by Teleflex Medical.
[75824716]
(b)(4). A visual, dimensional and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report. A device history record review shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint. However material from our current inventory was functionally inspected and no issues were detected that can lead this customer complaint. Regarding similar complaints from this same issue a capa (b)(4) was generated in order to further investigate this issue. If the device sample becomes available at a later date this complaint will be updated.
Patient Sequence No: 1, Text Type: N, H10
[75824717]
Customer complaint alleges that the staff reports the device with this lot number is defective. Customer alleges the device was tested, and "the neb just bubbled". Alleged malfunction reported as detected during pre-testing. No report of patient involvement. No report of patient harm or delay in treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00213 |
| MDR Report Key | 6587024 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-05-04 |
| Date Mfgr Received | 2017-07-06 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2017-05-24 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM |
| Generic Name | NEBULIZER, MEDICINAL,NON-VENTILATORY |
| Product Code | CCQ |
| Date Received | 2017-05-24 |
| Returned To Mfg | 2017-06-22 |
| Catalog Number | 1755 |
| Lot Number | 74B1702078 |
| 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 | 2017-05-24 |