MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/DUAL W; BREATHING CIRCUIT

Catalog Number 780-15

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

The customer alleges that the circuit did not pass the leak test.No pt injury.

Manufacturer Narrative

(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.The device history record of batch number 74l1402115 that belong to catalog number 780-15 has been reviewed and no issues or discrepancies were found which could potentially relate to this 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 our specifications.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 was no inventory of the involved product code available at the facility and it was not being mfg at the time.If device sample becomes available at a later date, this complaint will be re-opened.

• Brand Name: HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/DUAL W
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4563692
• MDR Text Key: 15244510
• Report Number: 3004365956-2015-00073
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-15
• Device Lot Number: 74L1402115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1