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 2018-07-13 for INTROCAN? SAFETY N/A 4251644-03 manufactured by B. Braun Melsungen Ag.
[113954755]
(b)(4). Device history record review (dhr): reviewed the device history record and no abnormalities found during in process and final control inspection. Sample evaluation: received one introcan safety pur 20g, 1. 1x32mm-ap catheter hub without original packaging, with its hub attached to an extension set. The cannula and the protective cap were not returned. By visually checking the received sample, the capillary of the sample was found damaged and the broken part of the capillary was found in a container upon receipt. Complaint and sample to be forwarded to production for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[113954756]
As reported by the user facility translation of user facility information by bbm sales organization in (b)(6): catheter in artery line was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00123 |
| MDR Report Key | 7687097 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-07-13 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-02-12 |
| Date Facility Aware | 2018-07-13 |
| Report Date | 2018-08-30 |
| Date Reported to FDA | 2018-08-30 |
| Date Reported to Mfgr | 2018-08-30 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-11-02 |
| Date Added to Maude | 2018-07-13 |
| 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 | 2018-07-13 |
| Returned To Mfg | 2018-07-02 |
| Model Number | N/A |
| Catalog Number | 4251644-03 |
| Lot Number | 17M02G8392 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-13 |