MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-02 for 5F DUAL VASCU-PICC MR17015206 manufactured by Medcomp.
[4926993]
Staff nurse noted swelling to the extremity where the picc line was inserted. The picc line was removed and an ultrasound was ordered by the md. Ultrasound reveals severe occlusive deep venous thrombosis which involves the left subclavian, axillary and brachial veins.
Patient Sequence No: 1, Text Type: D, B5
[12242884]
The device involved in the complaint was not returned for eval. A review of the mfg records indicated all device specifications and quality requirements were satisfied. Without evaluating the device involved in the complaint we are unable to determine the cause or factors which may have contributed to this event. Vascular thrombosis and mechanical phlebitis are known potential complications of this device and is listed in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518902-2014-00065 |
| MDR Report Key | 4142707 |
| Report Source | 05,06 |
| Date Received | 2014-10-02 |
| Date of Report | 2014-10-01 |
| Date of Event | 2014-08-23 |
| Date Mfgr Received | 2014-09-08 |
| Device Manufacturer Date | 2014-08-11 |
| Date Added to Maude | 2014-10-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SMITH, RN |
| Manufacturer Street | 1499 DELP DR. |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal | 19438 |
| Manufacturer Phone | 2152564201 |
| Manufacturer G1 | MEDCOMP |
| Manufacturer Street | 1499 DELP DR. |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5F DUAL VASCU-PICC |
| Generic Name | INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 2014-10-02 |
| Model Number | MR17015206 |
| Catalog Number | MR17015206 |
| Lot Number | MBVH580 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | HARLEYSVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-02 |