MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for CARDINAL HEALTH - STERILE CATH LAB TRAY SAN13CLMGD manufactured by Cardinal Health 200, Llc.
[130687203]
Two o. R tables were being prepped by sterile technique by both or circulating rn and o. R scrub tech. This preparation was for a tavr procedure when several small (~1mm) nylon-looking fibers were noted in the small sterile bowls filled with normal saline and heparinized saline. The ns fluid is used to prep the valve to be implanted. The hep saline is used for injecting into sheaths and catheters that are also in the body. Concern about these loose fibers is for potential embolus. These fibers appeared to be in both the white and blue bowls (white come with the table and blue are added). The bowls were removed from the table. New sterile bowls were dropped on table by sterile technique, and new bags of fluid were spiked with new decanters. Fluid was poured sterile technique into bowls. Fibers/lint again were noted. This was all repeated with "shaking" and "tapping" the bowls to try to make sure they did not have fibers in them to start. Particles still were present. Metal "pitchers" were obtained from or and these were used without any lint/fibers noted. All physicians and team members were notified. Manufacturer response for angiography/angioplasty kit, cardinal health (per site reporter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8174790 |
| MDR Report Key | 8174790 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-02 |
| Date of Event | 2018-10-30 |
| Report Date | 2018-12-02 |
| Date Reported to FDA | 2018-12-02 |
| Date Reported to Mfgr | 2018-12-18 |
| Date Added to Maude | 2018-12-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CARDINAL HEALTH - STERILE CATH LAB TRAY |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-12-18 |
| Model Number | SAN13CLMGD |
| Catalog Number | SAN13CLMGD |
| Lot Number | 107098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-18 |