MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-11 for DUAL CATH PICC 19 PIC 60DT manufactured by Luther Medical Products.
[5638]
Dl-l cath placed in svc - confirmed by x-ray. Iv rn attempted to remove guidewire, met with resistance leak noted within 1cm. Proximal to y junction.. Entire cath removed intact, another picc replaced without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18102 |
| MDR Report Key | 18102 |
| Date Received | 1994-08-11 |
| Date of Report | 1994-05-17 |
| Date of Event | 1994-04-20 |
| Date Added to Maude | 1994-12-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL CATH PICC |
| Generic Name | DOUBLE LUMEN PICC 18G |
| Product Code | GBP |
| Date Received | 1994-08-11 |
| Returned To Mfg | 1994-05-17 |
| Model Number | 19 PIC 60DT |
| Lot Number | LMP 1434 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18030 |
| Manufacturer | LUTHER MEDICAL PRODUCTS |
| Manufacturer Address | 14332 CHAMBERS RD. TUSTIN CA 92680 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-08-11 |