MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-04 for ABG-HM-1 manufactured by Hummingbird Med Devices, Inc..
[74472190]
Hummingbird med received a product complaint from baxter healthcare involving their interlink t-connector when used with a hummi micro draw blood transfer device. The customer tried to insert the hummi's blunt cannula in the middle of the interlink t-connector port. The t-connector's port caved-in and the patient started bleeding out. The hospital did not know how much blood was lost from the patient but the patient did need a blood transfusion. Hummingbird med has informed the hospital of improper use of the hummi and to use it only with an approved micro-t connector validated for use with the hummi.
Patient Sequence No: 1, Text Type: N, H10
[74472191]
Hummingbird med received a product complaint from baxter healthcare involving their interlink t-connector when used with a hummingbird med hummi micro draw blood transfer device. The customer tried to insert the hummi blunt cannula in the middle of the interlink t-connector port. The t-connector port caved-in and patient started bleeding out. The hospital did not know how much blood was lost from patient but the patient did need a blood transfusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009382876-2017-00001 |
| MDR Report Key | 6545515 |
| Report Source | OTHER |
| Date Received | 2017-05-04 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-04 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JORGE HAIDER |
| Manufacturer Street | 20371 LAKE FOREST BLVD |
| Manufacturer City | LAKE FOREST CA 92630 |
| Manufacturer Country | US |
| Manufacturer Postal | 92630 |
| Manufacturer Phone | 7605856525 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1908-2016 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BLOOD DRAW TRANSFER DEVICE |
| Product Code | KST |
| Date Received | 2017-05-04 |
| Model Number | ABG-HM-1 |
| Catalog Number | ABG-HM-1 |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUMMINGBIRD MED DEVICES, INC. |
| Manufacturer Address | 20371 LAKE FOREST BLVD LAKE FOREST CA 92630 US 92630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |