FDA Adverse Event Malfunction Summary report: N

HUDSON RESERVOIR, CONCHA MINI 760 ML

MDR report key: 3911844 · Received May 12, 2014

Report

Report Number: 1417411-2014-00032
Event Type: Malfunction
Date Received: May 12, 2014
Date of Event: May 1, 2014
Report Date: May 2, 2014
Manufacturer: TELEFLEX MEDICAL
Product Code: BTT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

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. DHR (DEVICE HISTORY RECORD) REVIEW OF MANUFACTURING EVENT LOG: SHOWS NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED, ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION AND ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. COMPLAINT NOT CONFIRMED. ROOT CAUSE UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO BOTTLES LEAKING AT THE PUNCTURE PORT FOUND PRIOR TO OR AT USE.

Description of Event or Problem · 1

THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BOTTLE WAS LEAKING AT THE PUNCTURE SITE. NO REPORT OF PATIENT INJURY/HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
283509	HUDSON RESERVOIR, CONCHA MINI 760 ML	RESERVOIR STERILE WATER	BTT	TELEFLEX MEDICAL		044140

Patients

Seq	Age	Sex	Outcome	Treatment
1