MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-14 for MERIT MINI ACCESS KIT 00884450012635 S-MAK401N/C manufactured by Merit Medical Systems Mexico.
[179483798]
The device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[179483799]
The account alleged that the catheter fractured within the patient. The detached portion was retrieved with a vascular snare device without any further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011642792-2020-00003 |
| MDR Report Key | 9712689 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-14 |
| 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. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS MEXICO |
| Manufacturer Street | 8830 SIEMPRE VIVA RD #100 |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT MINI ACCESS KIT |
| Generic Name | ACCESS KIT |
| Product Code | DRE |
| Date Received | 2020-02-14 |
| Model Number | 00884450012635 |
| Catalog Number | S-MAK401N/C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS MEXICO |
| Manufacturer Address | 8830 SIEMPRE VIVA RD #100 SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-02-14 |