MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG JVP 38# VENT PLUG 3/8

Catalog Number 70100.4997

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2014

Event Type  Injury  

Event Description

It was reported the surgeon clamped the cannulae,and the cannulae was ready for de-airing.The surgeon attempted to remove the plug, when the plug broke in half requiring the surgeon to "fish out" the broken bits.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) was not yet received the de-airing plug for evaluation.A supplemental medwatch will be submitted when additional info becomes available.

• Brand Name: JVP 38# VENT PLUG 3/8
• Type of Device: VENT PLUG 3/8
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4180001
• MDR Text Key: 5162543
• Report Number: 8010762-2014-00786
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 70100.4997
• Device Lot Number: 92140274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Required Intervention