MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN; BREATHING CIRCUIT

Catalog Number 780-07

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that a piece of small red plastic was found inside of the ventilator circuit.The alleged defect was found prior to patient use.

Manufacturer Narrative

Five (5) pictures of the product catalog number 780-07 (circuit, neonatal, dual htd limb w/18 in r) were received for analysis.They were visually inspected, it can only be identified as a small red contamination related with the complaint, but it is hard to appreciated the contamination type within the component of the circuit.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number (b)(4) has been reviewed and no issues or discrepancies were found related 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.This customer complaint can not be confirmed based on the received pictures since it is hard to appreciated the contamination type on the product, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If defective sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4182115
• MDR Text Key: 21451607
• Report Number: 3004365956-2014-00159
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/14/2014

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: Other
• Device Catalogue Number: 780-07
• Device Lot Number: 02L1301102
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1