MAUDE Adverse Event Report: HALYARD HEALTH KC400 OS WRAP 40X40; STERILIZATION WRAP KIMGUARD

Model Number 62240

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One unused sample which was not returned with the original packaging was received.The sterilization wrap was opened across the table in order to view the product in its entirety.After examining the quadrants of the wrap, the sample appeared to have a slit in the fabric.The slit is located in the middle section, top portion of the device (front layer) and penetrated through the (back layer) of the wrap.The device history record for lr5225 was reviewed and the product was produced according to product specifications.Halyard health 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 halyard health complaint database and identified as complaint 1054380-2016-00005.

Event Description

It was reported that there was a hole found in the wrap through 2 layers.No additional information was provided.

• Brand Name: KC400 OS WRAP 40X40
• Type of Device: STERILIZATION WRAP KIMGUARD
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): HALYARD NORTH CAROLINA, INC.; 389 clyde fitzgerald rd ; linwood NC 27299
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5686392
• MDR Text Key: 46200019
• Report Number: 1054380-2016-00005
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK082177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 62240
• Device Catalogue Number: 991062240
• Device Lot Number: LR5225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1