MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-02 for MAHURKAR ELITE 8888211416 manufactured by Covidien Mfg Solutions S.a..
[173528559]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173528560]
According to the reporter, the guide wire uncoiled during insertion. It was noted that the tip of the guide wire broke off in the insertion needle when retracted by the physician. The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue. Fluoroscopy was used to check if any guide wire pieces were left in the patient and it was stated to be negative. The kit was replaced by another product from a different manufacturer. There were no patient symptoms or complications noted associated with the event. The patient was reported to be deceased. The patient's death was reported not to be related to the alleged complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2020-00004 |
| MDR Report Key | 9540472 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-03-01 |
| Date Added to Maude | 2020-01-02 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAHURKAR ELITE |
| Generic Name | CATHETER, HEMODIALYSIS, NON-IMPLANTED |
| Product Code | MPB |
| Date Received | 2020-01-02 |
| Model Number | 8888211416 |
| Catalog Number | 8888211416 |
| Lot Number | 1835100092 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-02 |