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 2019-02-26 for INTROCAN? SAFETY N/A 4251644-01 manufactured by B. Braun Melsungen Ag.
[139217137]
(b)(4). We received 36 introcan safety pur 20g, 1. 1x32mm-eu in original closed packaging. 20 samples were subjected to a visual examination. We detected no damages or manufacturing faults. The 20 samples were taken to a visual examination according to test plan. Nominal clip position: both arms of the safety clip must be sitting in the groove of the housing. Actual: the clips of the samples are in the right position of the cannula housing. We detected no damages or manufacturing faults at the capillary housings. Furthermore 20 samples were taken to a funcktion test, the safety clip functional was tested according to the test plan. Nominal: pull out the needle hub about 5mm, rotate it 90?. Place and hold the housing firmly on a table, while the other hand is to pull the needle with clip completely out of the housing. The needle clip must be blocked and to test this, push the needle on a stretched rubber glove. The needle tip must not puncture through the glove. Actual: we detected no function faults at the samples. A resistance during withdrawing the cannula out of the capillary housing (for example due to a hooking of the clip at the raw cannula) was not detected on the tested samples. The special feature of a self-activating saftey clip is given. After pushing the needle on a stretched rubber glove the needle did not puncture through the glove. In addition the 20 samples were taken fot a visual examination again. At the clip or at the capillary housing no damages were detected. The tested samples are within our specifications. We have informed our manufacturing departement accordingly. The complained samples have been forwarded to our manufacturing site for evaluation. A follow-up report will be provided after the review of the batch and manufacturing records and statement are available.
Patient Sequence No: 1, Text Type: N, H10
[139217138]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): security system doesn? T work properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2019-00038 |
| MDR Report Key | 8370318 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-26 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-01-31 |
| Date Facility Aware | 2019-02-26 |
| Report Date | 2019-07-02 |
| Date Reported to FDA | 2019-07-02 |
| Date Reported to Mfgr | 2019-07-02 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2018-09-16 |
| Date Added to Maude | 2019-02-26 |
| 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 | 2019-02-26 |
| Returned To Mfg | 2019-02-20 |
| Model Number | N/A |
| Catalog Number | 4251644-01 |
| Lot Number | 18K16G8301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 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 | 2019-02-26 |