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

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.

• Brand Name: QUICK CHECK
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6646258
• MDR Text Key: 77721083
• Report Number: 6646258
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: LT6282, LT6292, LT6293 X2
• Other Device ID Number: LT6318 X2,LT6364 X4,LT6905,LT
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2017
• Type of Device Usage: N
• Patient Sequence Number: 1