MAUDE Adverse Event Report: HALYARD HEALTH KC200 OS WRAP 48X48; STERILIZATION WRAP

Model Number 62048

Device Problems Hole In Material (1293); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

Udi # unknown.(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Unable to determine root cause.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.(b)(4).

Event Description

It was reported that there were holes in the sterilization wraps.Additional information has been requested.

Manufacturer Narrative

The actual sample was received without original packaging.The sample had strips of paper tape affixed on one side.Visual evaluation revealed that the sample has strips of paper tape affixed on one side.The customer has circled the areas of concern on the sample.There were multiple occurrences of small holes in the sterilization wrap.Each hole measured approximately 1mm in size.The holes penetrated both layers of nonwoven.The manufacturing process was reviewed, and it was determined that this type of hole can only happens after the two layers of fabric are bonded together.No root cause for the reported event could be determined.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 (b)(4).

• Brand Name: KC200 OS WRAP 48X48
• Type of Device: STERILIZATION WRAP
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): HALYARD NORTH CAROLINA, INC.; 389 clyde fitzgerald road; linwood NC 27299
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5741069
• MDR Text Key: 47924877
• Report Number: 1054380-2016-00007
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 06/30/2016

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: 11/03/2020
• Device Model Number: 62048
• Device Catalogue Number: 991062048
• Device Lot Number: LT5307000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1