MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-24 for PORT-A-CATH 21-8000 manufactured by Pharmacy Deltech, Inc..
[5408]
Subclavian portocath insertion 7/15/92 for chemotherapydouble lumen catheterport-a-cathreorder 21-8000lot number 18861a
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16329 |
| MDR Report Key | 16329 |
| Date Received | 1994-01-24 |
| Date of Report | 1993-12-10 |
| Date of Event | 1993-12-08 |
| Date Facility Aware | 1993-12-08 |
| Report Date | 1993-12-10 |
| Date Added to Maude | 1994-09-22 |
| 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 |
| 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 | PORT-A-CATH |
| Generic Name | DOUBLE LUMEN CATHETER |
| Product Code | FGH |
| Date Received | 1994-01-24 |
| Model Number | 21-8000 |
| Lot Number | 18861A |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 16262 |
| Manufacturer | PHARMACY DELTECH, INC. |
| Manufacturer Address | 1265 GREY FOX RD. ST. PAUL MN 551126967 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-01-24 |