MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-10 for HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB 780-24 manufactured by Teleflex Medical.
[23834856]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received at our facility. A device history record review could not be conducted since the lot number was not provided. No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported. Customer complaint cannot be confirmed based only on the info provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is it being manufactured at the time. If device sample becomes available at a later date tis complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[23834857]
The customer alleges an occlusion issue due to crystallization of nebulized hypertonic saline within the neptune column on a ventilated pt. The occlusion caused a high pressure alarm on the vent. No pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00230 |
| MDR Report Key | 4996520 |
| Date Received | 2015-08-10 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-12 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD. |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 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 CIRCUIT, PEDIATRIC, DUAL LIMB |
| Generic Name | BREATHING CIRCUIT |
| Product Code | OFP |
| Date Received | 2015-08-10 |
| Catalog Number | 780-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-10 |