HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/DUAL W 780-15

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3004365956-2015-00271
MDR Report Key5020995
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-08-21
Date of Report2015-08-11
Date of Event2015-08-09
Date Mfgr Received2015-10-08
Device Manufacturer Date2015-03-02
Date Added to Maude2015-08-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/DUAL W
Generic NameBREATHING CIRCUIT
Product CodeCAG
Date Received2015-08-21
Returned To Mfg2015-08-19
Catalog Number780-15
Lot Number74C1500347
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.