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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH, INC. QUICK CHECK WRAP, STERILIZATION

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HALYARD HEALTH, INC. QUICK CHECK WRAP, STERILIZATION Back to Search Results
Lot Number LT6282, LT6292, LT6293 X2
Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 04/17/2017
Event Type  malfunction  
Event Description
The sterile processing team and operating room staff have ongoing concerns with the integrity of several of halyard's products. Staff have found holes in the wraps for sterile trays after introduction into the operating room sterile field. Staff must either procure new trays, or have the trays reprocessed. This causes unnecessary delay and is a major patient safety risk. Sterile processing has identified nearly 40 known defective products in the span of 11 days, which does not include products that may have been disposed. Manufacturer response for sterilization wrap, smart wrap (per site reporter) , smart wrap lot numbers were gathered at the manufacturer's request. Nineteen defective products with the following lot numbers were found in an 11 day period: 12396, 19017, am1702360, am1702360, am1702360, am1704660, am1704660, am1705360, am1705860, am1705860, am1707960, am1707960, am1707960, am1708760, am1710060, am1710060, am1710060, joa12 and joa12. Manufacturer response for sterilization wrap, quick check (per site reporter) several halyard representatives have responded to the concerns raised regarding their wraps. They indicated the issue may be with the process used, but the process has not changed and follows the manufacturer's guidelines for use. Quick check lot numbers were gathered at the manufacturer's request. Seventeen defective products with the following lot numbers were found in an 11 day period: lt6282, lt6292, lt6293, lt6293, lt6318, lt6318, lt6364, lt6364, lt6364, lt6364, lt6905, lt6964, lt7007, lt7007, lt7032, lt7042 and lt7122.
 
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Brand NameQUICK CHECK
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
HALYARD HEALTH, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key6646258
MDR Text Key77721083
Report Number6646258
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberLT6282, LT6292, LT6293 X2
Other Device ID NumberLT6318 X2,LT6364 X4,LT6905,LT
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2017
Event Location Hospital
Date Report to Manufacturer06/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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