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 2018-10-11 for INTROCAN? SAFETY N/A 4251644-03 manufactured by B. Braun Melsungen Ag.
[124674137]
(b)(4). This report has been identified as b. Braun (b)(4), internal report # (b)(4). No samples were returned. One photo has been provided. Further evaluation and investigation will be done based on photo given. The complaint is only taken to the knowledge and filed for statistical purpose. However, if the complaint sample is available, this complaint will be re-opened accordingly. Device history record review (dhr): a review of the device history record could not be performed, as the batch number is unknown. The complaint was forwarded to our manufacturing site for evaluation. If the sample or lot number and/or additional pertinent information becomes available, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[124674138]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): needle-stick injury of introcan safety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00219 |
| MDR Report Key | 7957093 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-11 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-06-08 |
| Date Facility Aware | 2018-10-11 |
| Report Date | 2018-11-13 |
| Date Reported to FDA | 2018-11-13 |
| Date Reported to Mfgr | 2018-11-13 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-10-11 |
| 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 | 2018-10-11 |
| Model Number | N/A |
| Catalog Number | 4251644-03 |
| Lot Number | UNKNOWN |
| 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 MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |