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U.S. Department of Health and Human Services

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

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HALYARD HEALTH KC600 OS WRAP 45X45 STERILIZATION WRAP KIMGUARD Back to Search Results
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 no lot number provided 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 three different incidences, which were associated with separate units, involving no patient contact. This is the second of three reports. Refer to 1054380-2016-00002 for the first 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 sealed seam has separated along one side. The customer has marked this seam "xx". Since the complaint information states that the customer has circled the areas of concern, this seam separation is noted as information only. 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. There is a visible pressure point seen in one of the circles, but it has not created a hole or tear. 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).
 
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Brand NameKC600 OS WRAP 45X45
Type of DeviceSTERILIZATION 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 Key5684116
MDR Text Key47190677
Report Number1054380-2016-00003
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK082177
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date02/25/2016
Device Model Number62645
Device Catalogue Number991062645
Device Lot Number6051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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