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

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. ".

• Type of Device: STERILIZATION 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 Key: 7553837
• MDR Text Key: 109634482
• Report Number: 1054380-2018-00002
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141071
• Number of Events Reported: 1
• 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 Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 34164
• Device Catalogue Number: 991034164
• Device Lot Number: LT7307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage