MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-25 for 7F X 60CM DUAL PRO LINE CT MR28037201 manufactured by Medcomp.
[18932874]
Pt in ct with right internal jugular venous double lumen power line rated at 5ml/sec. Line cleared for use and was flushed and good blood return. Upon injection of contrast a 4ml/sec. Graph showed rise, plateau and then sudden drop in pressure line was found busted with blood flowing out. Line immediately clamped off.
Patient Sequence No: 1, Text Type: D, B5
[19278326]
An investigation has been initiated. We are currently waiting to determine if the sample will be returned for evaluation. Requests for the sample have been made to the reported with no response to date. When the investigation is complete, a final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518902-2014-00041 |
| MDR Report Key | 3955787 |
| Report Source | 06 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-05-09 |
| Date Facility Aware | 2014-05-30 |
| Date Mfgr Received | 2014-05-30 |
| Device Manufacturer Date | 2013-10-12 |
| Date Added to Maude | 2014-07-31 |
| 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 | 7F X 60CM DUAL PRO LINE CT |
| Generic Name | INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 2014-06-25 |
| Model Number | MR28037201 |
| Catalog Number | MR28037201 |
| Lot Number | MFTM940 |
| ID Number | NA |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-06-25 |