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 2018-09-27 for INTROCAN? SAFETY N/A 4252527-03 manufactured by B. Braun Melsungen Ag.
[122634185]
(b)(4). Reviewed the device history record and no abnormalities found during in process and final control inspection. Received two used catheter hub of introcan safety fep 20g, 1. 1x45mm-ap in opened packaging. The cannula hub and protective cap was not returned for investigation. The sample was taken for investigation and observed that for 1 sample the capillary tip was broken off about 30mm from catheter horn. The broken area of the capillary exhibits a clear "v" cut shape. Visual inspection on the other sample did not show any broken off capillary. Broken off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and reject by the in-line vision system. Damages induced after assembly process is not possible since the catheter had been protected with protective cap. Based on the investigation, this defect is believed to be caused by reinserting the cannula into capillary which lead to the capillary being pierced and later got broken off during withdrawal. As communicated in ifu: warning section stated that: in the case of an unsuccessful iv start, remove the needle first to activate safety mechanism, then remove catheter from patient and discard both. After withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism. Do not bend the catheter/needle during insertion, advancement, or removal of the needle. Extreme care should be taken not to cut the catheter and possibly cause an embolism. Cause : defect due to wrong handling.
Patient Sequence No: 1, Text Type: N, H10
[122634186]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): catheter broken off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00203 |
| MDR Report Key | 7916717 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date Facility Aware | 2018-09-26 |
| Report Date | 2018-09-27 |
| Date Reported to FDA | 2018-09-27 |
| Date Reported to Mfgr | 2018-09-27 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2018-01-07 |
| Date Added to Maude | 2018-09-27 |
| 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 | 2018-09-27 |
| Returned To Mfg | 2018-09-12 |
| Model Number | N/A |
| Catalog Number | 4252527-03 |
| Lot Number | 18A07G8244 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 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 | 2018-09-27 |