MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADL ISOGARD DUAL HTD DUAL DRAIN CIRCUI

Catalog Number 880-36

Device Problem Crack (1135)

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

Event Date 03/09/2015

Event Type  malfunction  

Event Description

The customer alleges that the tubing was cracked at the collection cup.The alleged issue was detected during set-up.Another device was used.No report of patient injury or harm.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

• Brand Name: HUDSON ADL ISOGARD DUAL HTD DUAL DRAIN CIRCUI
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn reg. affairs ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4651087
• MDR Text Key: 5618194
• Report Number: 3004365956-2015-00106
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2015

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: Other
• Device Catalogue Number: 880-36
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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