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 2018-09-04 for INTROCAN? SAFETY N/A 4251601-01 manufactured by B. Braun Melsungen Ag.
[119044903]
(b)(4). We received one used capillary housing of an introcan safety pur 24g, 0. 7x19mm-eu without packaging. The introcan needle was not handed over by the customer. Furthermore we received a used promedicare iv extension line from a competitor. The returned capillary housing was taken to a visual inspection. On the received sample the capillary tube is detached from the capillary housing and the metal bush is not available. The detached capillary and the metal bush were not handed over by the customer. The definitive reason of the complaint could not comprehended by hc-pm, therefore we expected a statement of the manufacturer. Since we received no batch information from the customer, an examination if there were any abnormalities in the test- or manufacturing documentation of the complained art. -no. And batch is not possible.
Patient Sequence No: 1, Text Type: N, H10
[119044904]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): cannula seperated leaving tip in vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00182 |
| MDR Report Key | 7841696 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-08-08 |
| Date Facility Aware | 2018-09-04 |
| Report Date | 2018-12-04 |
| Date Reported to FDA | 2018-12-04 |
| Date Reported to Mfgr | 2018-12-04 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-09-04 |
| 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 | 2018-09-04 |
| Returned To Mfg | 2018-08-14 |
| Model Number | N/A |
| Catalog Number | 4251601-01 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-09-04 |