MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON 2PC VSYS W/9FR INTR KIT LW PFL; CATHETER INTRODUCER KIT

Model Number 120021

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

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

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, when the doctor opened the product, he found the sheath was already broken.

• Brand Name: 2PC VSYS W/9FR INTR KIT LW PFL
• Type of Device: CATHETER INTRODUCER KIT
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5388712
• MDR Text Key: 36765347
• Report Number: 1219930-2016-00063
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K961856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

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: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 120021
• Device Catalogue Number: 120021
• Device Lot Number: N2K0186X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1