MAUDE Adverse Event Report: HALYARD HEALTH KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP% KC 600% 54IN X 54IN; KIMGUARD ONESTEP STERILIZATION WRAP

Model Number 34142

Device Problem Hole In Material (1293)

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 no lot number was provided.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 five different incidences, which were associated with separate units.This is the fifth of five reports.Refer to 1054380-2016-00008 for the first report.Refer to 1054380-2016-00009 for the second report.Refer to 1054380-2016-00010 for the third report.Refer to 1054380-2016-00011 for the fourth report.It was reported that there were pinholes experienced five times during post-sterilization.The incidents was discovered in sterile processing and the instruments did not reach the operating room, and no patients were involved.No additional information was provided.

• Type of Device: KIMGUARD ONESTEP STERILIZATION WRAP
• 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: 5763178
• MDR Text Key: 49069835
• Report Number: 1054380-2016-00012
• 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
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 34142
• Device Catalogue Number: 991034142
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1