MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-19 for DELTEC? PROPORT PORTS IMPLANTABLE ACCESS SYSTEMS 21-4155-24 manufactured by Smiths Medical Asd; Inc..
[180635459]
One video was returned for analysis. From review of the video, it was observed that the plastic port assembly was loose. Relevant documents and manufacturing process were reviewed and deemed adequate. The ultrasonic weld operation, visual inspection process, set-up of ultrasonic welder, and training records were reviewed; no discrepancies were found. Based on the evidence, the complaint was confirmed. The root cause was found to be from manufacturing as the lack of knowledge of the operation of the welding machine and lack of process controls in the ultrasonic machine.
Patient Sequence No: 1, Text Type: N, H10
[180635460]
Information was received indicating that a patient receiving chemotherapy through a smiths medical deltec? Proport ports implantable access system was noted to have extravasation. Withdrawal was effectively performed to verify that structural failure occurred at the level of the union at the base of the reservoir and that it easily unclogs. The port was left in place and chemo has been continued via peripheral iv route. There were no further reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01377 |
| MDR Report Key | 9730096 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-02-19 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE MN 55128 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTEC? PROPORT PORTS IMPLANTABLE ACCESS SYSTEMS |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-02-19 |
| Model Number | 21-4155-24 |
| Catalog Number | 21-4155-24 |
| Lot Number | 3736572 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |