MAUDE Adverse Event Report: HALYARD HEALTH KC600 OS WRAP 45X45; STERILIZATION WRAP KIMGUARD

Model Number 62645

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as the lot number provided was not valid.Root cause could not 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).Device not returned.

Event Description

Halyard received a single report that referenced three different incidences, which were associated with separate units, involving no patient contact.This is the first of three reports.Refer to 1054380-2016-00003 for the second report.Refer to 1054380-2016-00004 for the third report.It was reported by the customer that, there is an issue with tearing on the sterilization wrap.This incident occurred post sterilization with no patient or instrument contact.No additional information was provided.

Manufacturer Narrative

The actual complaint product was returned for evaluation.One used sample was received with no packaging.The sample has sterilization indicator tape affixed to the outer layer.The wrap has a long jagged tear extending from one edge.This tear is not circled or indicated as being the concern from the customer.It has the appearance of having been purposefully torn, with some force.The customer circled two areas on the wrap.With visual inspection, no tears or holes are seen in the circled areas.These areas were then viewed under magnification.No holes or tears are seen under magnification.The reported failure is not confirmed based on the assessment of the circled areas.Root cause could not 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: KC600 OS WRAP 45X45
• 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 road; linwood NC 27299
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5684118
• MDR Text Key: 47192410
• Report Number: 1054380-2016-00002
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 62645
• Device Catalogue Number: 991062645
• Device Lot Number: 5560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1