MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for HUMMI ABG-HM-1 manufactured by Hummingbird Medical Devices, Inc.
[30042243]
Data indicates the y-connector was potentially molded undersized creating a smaller outside diameter of y leg as designed to fit into the corresponding hub. This went undetected by supplier. This created a loose fit not having a sufficiently strong enough bond.
Patient Sequence No: 1, Text Type: N, H10
[30042244]
A cannula hub (yellow in color) is bonded to a y-connector of the device. This bond joint was discovered to be insufficient (came apart) by the sale rep during routine visit at the hospital while handling the device. The experience of the sales rep prompted him to raise the question of the manufacturer since this had not preciously been experienced. This was a new e.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009382876-2015-00002 |
| MDR Report Key | 5182143 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-09-29 |
| Date Mfgr Received | 2015-09-29 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2015-10-27 |
| 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 STE6A LAKE FORREST DRIVE |
| Manufacturer City | LAKE FOREST CA 92630 |
| Manufacturer Country | US |
| Manufacturer Postal | 92630 |
| Manufacturer Phone | 9492156453 |
| Manufacturer G1 | YANTAI KAIBO AUTOMATION TECHNOLOGIES |
| Manufacturer Street | TAIWAN INDUSTRIAL PARK, MUPING |
| Manufacturer City | YANTAI CITY, SHANDONG PROVINCE 264114 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 264114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 29091501 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUMMI |
| Generic Name | BLOOD DRAW TRANSFER DEVICE |
| Product Code | KST |
| Date Received | 2015-10-27 |
| Model Number | ABG-HM-1 |
| Lot Number | 15180 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUMMINGBIRD MEDICAL DEVICES, INC |
| Manufacturer Address | LAKE FOREST CA 92630 US 92630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-27 |