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 2018-10-31 for INTROCAN? SAFETY N/A 4253566-03 manufactured by B. Braun Melsungen Ag.
[126517829]
(b)(4). Device history record (dhr): reviewed the dhr and no abnormality observed during in-process and at final control inspection. Samples for evaluation: received two (2) pieces of used capillary hubs of introcan safety-w pur 20g, 1. 1x32mm-ap without packaging. The cannula hubs and protective caps were not returned. Sample 1: observed part of the capillary has broken off measuring about 25mm. The other part of the capillary measured about 7mm still attached to the capillary hub. Sample 2: no broken capillary was observed. Investigation results: the broken area of the capillary shows it has been cut by sharp object and this defect happened during cannulation. As communicated in ifu, warning section stated that: after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism. Do not use scissors or sharp instruments at or near the insertion site. In conclusion, this defect is due to wrong handling. Complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[126517830]
As reported by the user facility (b)(4): catheter broken when needle removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00232 |
| MDR Report Key | 8025648 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date Facility Aware | 2018-10-31 |
| Report Date | 2018-10-31 |
| Date Reported to FDA | 2018-10-31 |
| Date Reported to Mfgr | 2018-10-31 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2017-09-26 |
| Date Added to Maude | 2018-10-31 |
| 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 | 2018-10-31 |
| Returned To Mfg | 2018-10-23 |
| Model Number | N/A |
| Catalog Number | 4253566-03 |
| Lot Number | 17K26G8274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 13 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 | 2018-10-31 |