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 2020-02-10 for IRRIGATION SET 7B3062 manufactured by B. Braun Medical Inc..
[182933318]
This report has been identified as b. Braun medical internal report number (b)(4). As reported by the user facility, it has been confirmed that no samples are available for further evaluation. 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
[182933319]
As reported by the user facility: on the irrigation set, the roller clamp is flimsy. The roller wheel does not easily turn or does not clamp at all.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00034 |
| MDR Report Key | 9686232 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-08-12 |
| Date Added to Maude | 2020-02-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BOULEVARD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| Manufacturer G1 | B. BRAUN DOMINICAN REPUBLIC, INC. |
| Manufacturer Street | LAS AMERICAS INDUSTRIAL PARK KM22 AUTOPISTA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2020-02-10 |
| Catalog Number | 7B3062 |
| Lot Number | 0061685595 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |