MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-30 for DISCOFIX? 409511CN manufactured by B. Braun Melsungen Ag.
[187874920]
This report has been identified as b. Braun melsungen ag internal report # (b)(4). No sample has been returned for investigation. We received one photo of a discofix-3 blue. The photo shows a leakage. However, it cannot be determined from where the leakage has originated or what the root cause of the leakage is. If the sample and/or additional pertinent information becomes available, a follow up report will be submitted. The manufacturing documentation and machine papers have been checked. There are no deviation or entries noted which could lead to a failure as complained. Besides, 5 pcs retained samples have been visual checked as well. There are no abnormalities observed. Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc.
Patient Sequence No: 1, Text Type: N, H10
[187874921]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): serious adverse event. Discofix 3-way stopcock was used for infusion and pressure monitoring of icu patient. 8 hours later it was found that the discofix was broken and liquid leaked. Vasoactive drug was not infused properly. Ventilator alarm showed patient's blood pressure decreased. The discofix was replaced immediately. After detection of the leakage, emergency treatment was given and the patient has recovered. Due to covid-19 pandemic, no sample available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2020-00072 |
| MDR Report Key | 9898420 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2020-03-30 |
| 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 BLVD. |
| Manufacturer City | ALLENTOWN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 2408332 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOFIX? |
| Generic Name | ACCESSORIES, CATHETER |
| Product Code | KGZ |
| Date Received | 2020-03-30 |
| Catalog Number | 409511CN |
| Lot Number | 18L2892041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |