MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for STERILE CATHETER LAB TRAY DYNJ58788 manufactured by Medline Industries, Inc.
[111733848]
Patient Sequence No: 1, Text Type: N, H10
[111733849]
Patient on the table to get a pacemaker implant. Scrub tech opened the sterile cath lab pack and started to drop sterile items for the case on the sterile table. The scrub tech noticed a big finger nail on the sterile table. We had to clean everything up and redo the sterile table and re-prep the patient. Manufacturer response for sterile catheter lab tray, medline industries inc. , (per site reporter): come and inspect the cath lab and refund everything we opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7618979 |
| MDR Report Key | 7618979 |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-06-08 |
| Report Date | 2018-06-14 |
| Date Reported to FDA | 2018-06-14 |
| Date Reported to Mfgr | 2018-06-14 |
| Date Added to Maude | 2018-06-20 |
| 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 | STERILE CATHETER LAB TRAY |
| Generic Name | CARDIAC CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2018-06-20 |
| Model Number | DYNJ58788 |
| Catalog Number | DYNJ58788 |
| Lot Number | 18DB3042 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |