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 2020-03-06 for MULTI-AD? 513501 manufactured by B. Braun Medical Inc..
[182938541]
This report has been identified as b. Braun medical internal report number (b)(4). No sample and/or lot number was provided for further evaluation. Without the actual device and/or lot number, a thorough investigation could not be performed. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[182938542]
As reported by the user facility: customer identified another particle in an ampicillin/sulbactam 40mg/ml dilution. Customer stated that they have continued to find small particles dilution bags. Some technicians stated that they only can see these particles in the bag after a day or two from initial production. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00064 |
| MDR Report Key | 9800841 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-06 |
| 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. JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 7197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-AD? |
| Generic Name | DISPENSER, LIQUID MEDICATI |
| Product Code | KYX |
| Date Received | 2020-03-06 |
| Model Number | 513501 |
| Catalog Number | 513501 |
| 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 | 901 MARCON BLVD. ALLENTOWN, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |