MAUDE Adverse Event Report: HALYARD HEALTH H300 SURGICAL ACM NON-STERILE; SURGICAL DRAPES AND PACKS

Model Number	44724
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation at the time this report was filed.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 31may2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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 (b)(4).Device not returned.
Event or Problem Description
It was reported that, the drapes in the cardiac cath packs are leaving these white flecks on our patients and on the sterile field.There was not just a few flakes as it gets all over the patient's skin.The hospital alleges that these flakes could get into the pacemaker pocket.No additional information was provided.

• Brand Name: H300 SURGICAL ACM NON-STERILE
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6604174
• Report Number: 3005997949-2017-00001
• Device Sequence Number: 10819281
• Product Code: CAZ
• UDI-Device Identifier: 30680651447242
• UDI-Public: 30680651447242
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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
• Operator of Device: Other Health Care Professional
• Device Model Number: 44724
• Device Catalogue Number: 104472400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/01/2017
• Patient Sequence Number: 1