MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for APEX? 601223 manufactured by B. Braun Medical Inc.
[187073211]
Event 1. This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[187073212]
As reported by the user facility: event 1: customer has received complaints that their tpn bags are running out before they should. This occurred with two (2) patients. This report is for patient #1, adult patient. Customer reported that all bags that ran dry had total expected weight to total weight variances of 1% to 1. 5%. Some of the variances in total weight were overweight and some were underweight. There was no harm caused to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1641965-2020-00002 |
| MDR Report Key | 9699308 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2017-11-29 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Manufacturer G1 | B. BRAUN MEDICAL INC |
| Manufacturer Street | 1601 WALLACE DRIVE, SUITE 150 |
| Manufacturer City | CARROLLTON TX 750066690 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 750066690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX? |
| Generic Name | COMPOUNDER |
| Product Code | NEP |
| Date Received | 2020-02-12 |
| Model Number | 601223 |
| Catalog Number | 601223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC |
| Manufacturer Address | 1601 WALLACE DRIVE, SUITE 150 CARROLLTON TX 750066690 US 750066690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |