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 4253540-03 manufactured by B. Braun Melsungen Ag.
[122011958]
(b)(4). Reviewed the device history record of the complaint batch and no abnormality found during in-process and at final control inspection. Received 1 used catheter hub of introcan safety-w pur 22g, 0. 9x25mm-ap without packaging and a new extension set. The cannula hub and protective cap was not returned for investigation. The sample was taken for investigation and observed that the capillary tip was broken off about 12mm from catheter horn. Broken off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected by the in-line vision system. Damages induced after assembly process is not possible since the catheter had been protected with the protective cap. The simulation by cannula reinsertion did not produce similar defect as per complaint sample. The complaint sample defect matches with the simulation sample of being cut by sharp object such as a scissors or scalpel. The defect on the complaint sample is believed to be occurred after the cannulation process due to been cut by a sharp tool. 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. Cause: defect due to wrong handling.
Patient Sequence No: 1, Text Type: N, H10
[122011959]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): broken pipe of indwelling needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00202 |
| MDR Report Key | 7916715 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-27 |
| Date of Event | 2018-08-24 |
| 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 | 2017-05-12 |
| 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 | 4253540-03 |
| Lot Number | 17E12G8316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 16 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 |