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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH QUICK CHECK* H600 STERILIZATION WRAP, 45IN. X 45IN. (114CM X 114CM) STERILIZATION PRODUCTS

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HALYARD HEALTH QUICK CHECK* H600 STERILIZATION WRAP, 45IN. X 45IN. (114CM X 114CM) STERILIZATION PRODUCTS Back to Search Results
Model Number 34164
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress. Upon completion of the sample evaluation and investigation; a follow-up report will be filed. All information reasonably known as of 30may2018 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 and identified as complaint (b)(4).
 
Event Description
It was reported by the customer that a hole was discovered in a sterilization wrap post or use. Additional information was received (b)(6) 2018 from customer that states, "there was no patient harm and the hole was seen before patient care started. ".
 
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Type of DeviceSTERILIZATION PRODUCTS
Manufacturer (Section D)
HALYARD HEALTH
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
HALYARD NORTH CAROLINA, INC.
1300 orchard hill road
linwood NC 27299
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key7553837
MDR Text Key109634482
Report Number1054380-2018-00002
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number34164
Device Catalogue Number991034164
Device Lot NumberLT7307
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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