MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-16 for 4F X 55CM SINGLE PRO-PICC CT MRCTP41017 manufactured by Medcomp.
[15814032]
During routine placement of a picc line, the dilator sheath became detached from the winged set prior to breaking and peeling apart.
Patient Sequence No: 1, Text Type: D, B5
[15955479]
An investigation has been initiated. The device sample was forwarded to the manufacturing facility for evaluation. When the investigation is complete, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518902-2014-00067 |
| MDR Report Key | 4188447 |
| Report Source | 05,06 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-10-15 |
| Date of Event | 2014-08-25 |
| Date Mfgr Received | 2014-09-24 |
| Device Manufacturer Date | 2014-06-05 |
| Date Added to Maude | 2014-10-30 |
| 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 |
| 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 | 4F X 55CM SINGLE PRO-PICC CT |
| Generic Name | INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 2014-10-16 |
| Returned To Mfg | 2014-09-24 |
| Model Number | MRCTP41017 |
| Catalog Number | MRCTP41017 |
| Lot Number | MBTR000 |
| ID Number | NA |
| Device Expiration Date | 2016-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-10-16 |