MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for PRIMARY PLUM SET / CLAVE Y - SITE, SECURE LOCK, 104 INCH manufactured by Icu Medical.
[144467344]
Iv line flushed with normal saline prior to administering rhogam, then again post administration. When the infusing iv fluid was restarted, the tubing began leaking into the bedding and wasn't flowing through the tubing. There wasn't a problem with the iv site or heplock. Because the problem began just after the administration of rhogam, we cannot say with 100% certainty that none of the blood product leaked out as well. Packaging was not saved. Multiple tubing packs in supply area with different lot numbers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8590837 |
| MDR Report Key | 8590837 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-04-13 |
| Report Date | 2019-04-16 |
| Date Reported to FDA | 2019-04-16 |
| Date Reported to Mfgr | 2019-05-08 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PRIMARY PLUM SET / CLAVE Y - SITE, SECURE LOCK, 104 INCH |
| Generic Name | IV TUBING |
| Product Code | GAZ |
| Date Received | 2019-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL |
| Manufacturer Address | 4455 ATHERTON DR. SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-08 |