FDA Adverse Event Malfunction Summary report: N

HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR

MDR report key: 3833116 · Received March 24, 2014

Report

Report Number: 1417411-2014-00017
Event Type: Malfunction
Date Received: March 24, 2014
Date of Event: March 6, 2014
Report Date: March 7, 2014
Manufacturer: TELEFELX MEDICAL
Product Code: BTT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO DHR (DEVICE HISTORY RECORD) WAS REVIEWED BECAUSE THE CUSTOMER DID NOT PROVIDED LOT NUMBER OF THE PRODUCT 003-40. A CORRECTIVE ACTION CANNOT BE APPLIED SINCE IT IS NOT POSSIBLE TO IDENTIFY THE DEFECT REPORTED AND TO INVESTIGATE ITS ROOT CAUSE, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. HOWEVER CURRENT PRODUCTION WAS VERIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFO PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. HOWEVER 28 SUB-ASSEMBLY INVOLVING MOLDED COMPONENTS MP-0318 AND MP-0489 WERE ASSEMBLY TRYING TO DUPLICATE THE PROBLEM REPORTED. THESE SAMPLES WERE ASSEMBLY IN TO A FLOW METER NLC06312 WHICH CONTAINS AND STANDARD MALE THREAD 9/16". NO ISSUES WERE FOUND THAT CAN LEAD THIS COMPLAINT. IF THE DEFECTIVE SAMPLE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE UPDATED WITH THE EVAL RESULTS.

Description of Event or Problem · 1

THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE WING NUT ON THE DEVICE WILL NOT ENGAGE ON THE THREADS OF THE GAS SUPPLY PORT. THE ADAPTER WAS CHANGED OUT FOR ANOTHER ONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
172188	HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR	BUBBLE HUMIDIFIER	BTT	TELEFELX MEDICAL

Patients

Seq	Age	Sex	Outcome	Treatment
1