MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for ACS CDVA23G manufactured by American Contract Systems, Inc..
[178568768]
We just opened 2 sterile packs that were both contaminated due to the outer drape of the pack being damaged. They were both vascular access packs lot#664191 it does not appear that all of the packs with this lot number are damaged but we did open 2 of them that were, the outer wrapper appears fine but the actual drape is compromised that actually ends up covering the table. Therefore the whole system has to be discarded. Possible that the positioning of the plastic supplies in the packs contributed to the holes. Underlying the hole are the plastic pitcher and bowl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693361 |
| MDR Report Key | 9693361 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-22 |
| Report Date | 2020-01-24 |
| Date Reported to FDA | 2020-01-24 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| 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 | ACS |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2020-02-11 |
| Model Number | CDVA23G |
| Lot Number | 664191 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEMS, INC. |
| Manufacturer Address | 7802 E TELECOM PKWY TAMPA FL 33637 US 33637 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |