MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-16 for QUICK CHECK manufactured by Halyard Health, Inc..
[77721082]
Patient Sequence No: 1, Text Type: N, H10
[77721083]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6646258 |
| MDR Report Key | 6646258 |
| Date Received | 2017-06-16 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-04-17 |
| Report Date | 2017-06-07 |
| Date Reported to FDA | 2017-06-07 |
| Date Reported to Mfgr | 2017-06-07 |
| Date Added to Maude | 2017-06-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICK CHECK |
| Generic Name | WRAP, STERILIZATION |
| Product Code | FRG |
| Date Received | 2017-06-16 |
| Lot Number | LT6282, LT6292, LT6293 X2 |
| ID Number | LT6318 X2,LT6364 X4,LT6905,LT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |