MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-10 for DELTEC? PORT-A-CATH? PROPORT 21-4153-24 manufactured by Smiths Medical Asd; Inc..
[182711290]
Information was received indicating that a filtration problem occurred to a smiths medical deltec? Port-a-cath? Proport. It was decided to not use the port for chemotherapy administration and the port was then explanted. Upon explant of the port, it reported that the base of the reservoir had detached causing serum extravasation. The patient required surgical intervention and had a new port placed. No further adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01929 |
| MDR Report Key | 9810967 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-07-11 |
| Date Added to Maude | 2020-03-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTEC? PORT-A-CATH? PROPORT |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 21-4153-24 |
| Catalog Number | 21-4153-24 |
| Lot Number | 3829676 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |