MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-21 for HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/DUAL W 780-15 manufactured by Teleflex Medical.
[23688980]
(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. The device history record review showed that there were no issues related to function neither on the product nor its components during the manufacture of the material. No corrective action can be established at this time without the device sample or picture for evaluation. Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause. 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 and it is not being manufactured at the time. If the device sample becomes available this compliant will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[23688981]
The customer alleges that the circuit occluded during use on a patient. No report of patient harm.
Patient Sequence No: 1, Text Type: D, B5
[27970207]
(b)(4). The sample was returned for evaluation. A visual exam was performed and an obstruction was found on the internal diameter of the tube/adaptor connection caused by a thin film. The film was partially occluding the adaptor. In order to try to replicate the failure mode, several samples were prepared applying intentionally excessive adhesive around the internal diameter of the tube and inserting the adaptor. A similar obstruction was created on the adaptor. Although work instruction indicates that the adhesive must be applied to the adaptor, when adhesive is applied inside the tube, any excess will be dragged by the connector and rested over the internal cross shape of the adaptor, obstructing or occluding the flow. The customer complaint was confirmed based on the visual inspection of the received sample. A capa was opened to address the issue.
Patient Sequence No: 1, Text Type: N, H10
[27970208]
The customer alleges that the circuit occluded during use on a patient. No report of patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00271 |
| MDR Report Key | 5020995 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-08-09 |
| Date Mfgr Received | 2015-10-08 |
| Device Manufacturer Date | 2015-03-02 |
| Date Added to Maude | 2015-08-21 |
| 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 | 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 CIRCUIT,NEONATAL,DUAL HTD LIMB W/DUAL W |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-08-21 |
| Returned To Mfg | 2015-08-19 |
| Catalog Number | 780-15 |
| Lot Number | 74C1500347 |
| 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 | 2015-08-21 |