MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for HALYARD QUICK CHECK 34147 manufactured by Halyard Health, Inc..
[62717023]
Patient Sequence No: 1, Text Type: N, H10
[62717024]
Sterile processing technician went to use the sterilization wrap to prepare surgical trays for sterilization when they noticed the wrap's top layer was coming apart from the bottom layer of the wrap. This caused a delay in sterilizing the trays since they had to find wrap that worked. Manufacturer response for sterilization wrap 48x48, halyard* quick check* sterilization wrap (per site reporter): they have sent in replacement product and want to pick up the affected lot.
Patient Sequence No: 1, Text Type: D, B5
[74642982]
Patient Sequence No: 1, Text Type: N, H10
[74642983]
Sterile processing - technician went to use the sterilization wrap to prepare surgical trays for sterilization when they noticed the wrap's top layer was coming apart from the bottom layer of the wrap. This caused a delay in sterilizing the trays since they had to find wrap that worked. Manufacturer response for sterilization wrap 48x48, halyard quick check sterilization wrap (per site reporter): they have sent in replacement product and want to pick up the affected lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6185055 |
| MDR Report Key | 6185055 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-22 |
| Report Date | 2016-11-23 |
| Date Reported to FDA | 2016-11-23 |
| Date Reported to Mfgr | 2016-11-23 |
| Date Added to Maude | 2016-12-19 |
| 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 | HALYARD QUICK CHECK |
| Generic Name | WRAP, STERILIZATION |
| Product Code | FRG |
| Date Received | 2016-12-19 |
| Model Number | 34147 |
| Catalog Number | 34147 |
| Lot Number | LT6288000 |
| ID Number | 48X48 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-12-19 |