MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-12 for CATH LAB KIT 46087-37 manufactured by Icu Medical, Inc..
[5036934]
Complaint received reporting air in line/component issues with use of one 46087-37 cath lab kit. It was reported that the 46087-37 ".. Manifold was prepped and after first catheter was inserted, air was introduced into the closed system via the contrast stopcock". There were no reported adverse patient consequences and or outcomes. Device return: pending.
Patient Sequence No: 1, Text Type: D, B5
[12545829]
Initial investigation: a review of the mfg. Lot build database for the reported lot # 2869345 (mfg. Date 05/2014) shows (b)(4) units were mfg. Tested inspected and released. There were no exception documents generated during the mfg. Lot build.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025816-2014-00097 |
| MDR Report Key | 4215361 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-12 |
| Date of Report | 2014-07-21 |
| Date of Event | 2014-06-26 |
| Date Facility Aware | 2014-06-26 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | TERRY SCESNY |
| Manufacturer Street | 4455 ATHERTON DR. |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATH LAB KIT |
| Generic Name | CATH LAB KIT |
| Product Code | OES |
| Date Received | 2014-08-12 |
| Model Number | 46087-37 |
| Catalog Number | 46087-37 |
| Lot Number | 2869345 |
| ID Number | PR# 26235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-12 |