MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-13 for INTROCAN? SAFETY N/A 4251687-01 manufactured by B. Braun Melsungen Ag.
[130493861]
(b)(4). No samples returned and no photos provided for this notification. Further evaluation and investigation cannot be concluded. The complaint is only taken to the knowledge and filed for statistical purpose. Reviewed the device history record and no abnormalities found during in process and final control inspection.
Patient Sequence No: 1, Text Type: N, H10
[130493862]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): catheter migration through the vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00265 |
| MDR Report Key | 8160550 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-08-16 |
| Date Facility Aware | 2018-12-13 |
| Report Date | 2018-12-13 |
| Date Reported to FDA | 2018-12-13 |
| Date Reported to Mfgr | 2018-12-13 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2018-12-13 |
| 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 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| 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 | INTROCAN? SAFETY |
| Generic Name | I.V. SAFETY CATHETER |
| Product Code | DQR |
| Date Received | 2018-12-13 |
| Model Number | N/A |
| Catalog Number | 4251687-01 |
| Lot Number | 18D13G8362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| 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 | 2018-12-13 |