MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-30 for PRESOURCE OR PROCEDURE SET UP PACK SUT21MBARC manufactured by Cardinal Health 200 Llc.
[53449939]
Patient Sequence No: 1, Text Type: N, H10
[53449940]
A scrub tech opened up a sterile major basin kit to set up for a scheduled surgery. When the scrub tech pulled out the raytec sponges, the scrub tech noticed the sponges were dirty with a dried unknown substance. The dirty sponges along with the rest of the major basin pack was removed. Another set up pack was used to complete the room set up. Manufacturer response for xray sponge in or procedure set up pack, presource by cardinal (per site reporter): the (b)(4) distribution sales rep was notified. He said he would contact our presource pack rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5913316 |
| MDR Report Key | 5913316 |
| Date Received | 2016-08-30 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-17 |
| Report Date | 2016-08-29 |
| Date Reported to FDA | 2016-08-29 |
| Date Reported to Mfgr | 2016-08-29 |
| Date Added to Maude | 2016-08-30 |
| 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 | PRESOURCE OR PROCEDURE SET UP PACK |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-08-30 |
| Model Number | SUT21MBARC |
| Catalog Number | SUT21MBARC |
| Lot Number | 536352 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-30 |