MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-10 for FLUID DISPENSING CONNECTOR 415080 manufactured by B. Braun Medical Inc..
Report Number | 2523676-2019-00154 |
MDR Report Key | 8980190 |
Date Received | 2019-09-10 |
Date of Report | 2019-09-30 |
Date Mfgr Received | 2019-08-15 |
Device Manufacturer Date | 2019-01-28 |
Date Added to Maude | 2019-09-10 |
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 | 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 | 0 |
Brand Name | FLUID DISPENSING CONNECTOR |
Generic Name | DISPENSER, LIQUID MEDICATI |
Product Code | KYX |
Date Received | 2019-09-10 |
Returned To Mfg | 2019-09-04 |
Catalog Number | 415080 |
Lot Number | 0061657808 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | B. BRAUN MEDICAL INC. |
Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-10 |