MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-28 for B.BRAUN 470182 manufactured by B. Braun Dominican Republic Inc..
[122046679]
(b)(4). The sample has been received and the investigation is ongoing at this time. A follow-up report will be submitted when the results of the investigation become available.
Patient Sequence No: 1, Text Type: N, H10
[122046680]
As reported by the user facility: the iv connector broke apart at the one way valve, causing blood to leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614279-2018-00173 |
| MDR Report Key | 7918448 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-28 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2018-09-28 |
| 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 | JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B.BRAUN |
| Generic Name | NEEDLEFREE COLLECTION SYST |
| Product Code | FNY |
| Date Received | 2018-09-28 |
| Returned To Mfg | 2018-11-21 |
| Catalog Number | 470182 |
| Lot Number | 0061609993 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN DOMINICAN REPUBLIC INC. |
| Manufacturer Address | LAS AMERICAS INDUSTRIAL PARK KM22 AUTOPISTA LAS AMERICAS SANTO DOMINGO, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |