MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2003-11-03 for TRIPLE LUMEN CATHETER XTP3118MT manufactured by Medcomp.
[318111]
It was reported that the "guidewire broke during withdrawal".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2003-00131 |
| MDR Report Key | 493478 |
| Report Source | 01,05,07,08 |
| Date Received | 2003-11-03 |
| Date of Report | 2003-10-08 |
| Date of Event | 2003-10-03 |
| Date Mfgr Received | 2003-10-08 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2003-11-05 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | TRIPLE LUMEN CATHETER |
| Generic Name | INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 2003-11-03 |
| Returned To Mfg | 2003-10-28 |
| Model Number | NA |
| Catalog Number | XTP3118MT |
| Lot Number | M340020 |
| ID Number | NA |
| Device Expiration Date | 2005-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 482184 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | 11.5FX 20CM TRIPLE LMN CATH |
| Baseline Generic Name | INFUSION CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | XTP3118MT |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-11-03 |