MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-16 INTRODUCER KIT; ENTERAL FEED PERCUTANEOUS

Model Number 98432

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Udi # unknown.(b)(4).The device history record for aa6095r02 was reviewed and the product was produced according to product specifications.Two of the three sutures included in the kit were returned without original packaging.The t-bar, needle, and guidewire components were also not returned with the samples.Visual inspection revealed that the samples were received with the soft shell attached to the clamp base.They also showed signs where the suture had prematurely separated from the t-bar.No root cause could be determined.(b)(4) has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the (b)(4) complaint database and identified as complaint (b)(4).

Event Description

It was reported that two of the stitches broke during placement.No injury to patient.No further information has been make available at this time.

• Type of Device: ENTERAL FEED PERCUTANEOUS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5973966
• MDR Text Key: 55788667
• Report Number: 9611594-2016-00131
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 98432
• Device Catalogue Number: 991098432
• Device Lot Number: AA6095R02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1