FDA Adverse Event Malfunction Summary report: N

HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,INT

MDR report key: 5367383 · Received January 14, 2016

Report

Report Number: 1417411-2016-00004
Event Type: Malfunction
Date Received: January 14, 2016
Date of Event: January 1, 2016
Report Date: January 5, 2016
Manufacturer: TELEFLEX MEDICAL
Product Code: BTT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

QN#(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 REVIEW SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT MP-0321 (SNAP-ON FLOWMETER ADAPTOR) BATCH # 2-2015741, 2-2015742, 5-1915742, 7-1915741 & 71915742 DURING THE MANUFACTURE OF THE MATERIAL. CUSTOMER COMPLAINT CANNOT BE CONFIRMED, BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM A CORRECT INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. A CAPA FILE #(B)(4) WAS OPENED TO PERFORM A FURTHER INVESTIGATION INTO THIS ISSUE (THIS CAPA IS OWNED BY (B)(4)). ACCORDING TO THE CAPA INVESTIGATION SO FAR THE ROOT CAUSE FOR THE ISSUE WAS THE POSITIONING OF THE THREAD LEAD AND THE SOFTNESS OF THE NEW RESIN USED FOR THE SNAP ADAPTOR. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

Description of Event or Problem · 1

THE CUSTOMER ALLEGES THAT THE ADAPTOR DOES NOT FIT THE FLOWMETER WELL. NO PATIENT INJURY/HARM REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
24690	HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,INT	RESPIRATORY GAS HUMIDIFIER	BTT	TELEFLEX MEDICAL		106156

Patients

Seq	Age	Sex	Outcome	Treatment
1				FLOWMETER