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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: O&M HALYARD INC. QUICK CHECK* H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) STERILIZATION PRODUCTS

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O&M HALYARD INC. QUICK CHECK* H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) STERILIZATION PRODUCTS Back to Search Results
Model Number 34145
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of (b)(6) 2018 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 o&m halyard 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 o&m halyard. O&m halyard,inc. 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 o&m halyard complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc. , product is defective or caused serious injury.
 
Event Description
It was reported that there were holes fond on the white side of the sterilization wrap. The holes were detected after use. Additional information was reported on (b)(6) 2018 that sttes, "the objects which wrapped with the product in question and sterilized wre used to the patient but no patient injury reported".
 
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Type of DeviceSTERILIZATION PRODUCTS
Manufacturer (Section D)
O&M HALYARD INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
HALYARD NORTH CAROLINA, LLC.
389 clyde fitzgerald road
linwood NC 27299
Manufacturer Contact
carolyn waits
5405 windward parkway
alpharetta, GA 30004
4704485136
MDR Report Key7897689
MDR Text Key121014733
Report Number1054380-2018-00003
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K082177
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 10/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number34145
Device Catalogue Number991034145
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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