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 2018-09-19 for INTROCAN? SAFETY N/A 4253523-03 manufactured by B. Braun Melsungen Ag.
[120762375]
(b)(4). Preliminary investigation: we received: one used (contaminated) capillary hub of introcan safety-w pur 24g, 0. 7x19mm-ap without packaging. Cannula hub and protective cap was not returned for investigation. The returned sample was taken to a visual examination. We observed that a part of the capillary is broken off. We have informed our manufacturing department accordingly and forwarded the sample for further investigation. A follow-up report will be provided after the statement is available. Device history record (dhr): reviewed the dhr of the complaint batch and no abnormality found during in-process and at final control inspection.
Patient Sequence No: 1, Text Type: N, H10
[120762376]
As reported by the user facility ((b)(4)): needle catheter rupture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00199 |
| MDR Report Key | 7890653 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-19 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-08-23 |
| Date Facility Aware | 2018-09-19 |
| Report Date | 2018-11-13 |
| Date Reported to FDA | 2018-11-13 |
| Date Reported to Mfgr | 2018-11-13 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2017-11-30 |
| Date Added to Maude | 2018-09-19 |
| 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 | 2018-09-19 |
| Returned To Mfg | 2018-09-12 |
| Model Number | N/A |
| Catalog Number | 4253523-03 |
| Lot Number | 17M30G8363 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 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 | 1. Required No Informationntervention | 2018-09-19 |