MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-03-24 for PORT-A-CATH II INTRASPINAL ACCESS SYSTEM 21-1500-22 manufactured by Smiths Medical Asd Inc.,.
[41052909]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[41052910]
From clinical trial study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug. According to reporter, a contrast study on (b)(6) 2016 showed extravasation from the catheter at the lower lumbar. A long split was noted in the catheter. An attempt was made at cutting and reconnecting the catheter using a connector from the lumbar drain, but the connector was too big. Therefore, the old port was replaced the device was surgically explanted from patient on an unscheduled basis (b)(6) 2016. Clinical trial study organizer reported that the access system was replaced with another system after explant. The patient was discharged from hospital on (b)(6) 2016. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183502-2016-00605 |
| MDR Report Key | 5522823 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-24 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-02-26 |
| Date Added to Maude | 2016-03-24 |
| 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 | MS. MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7633833052 |
| Manufacturer G1 | SMITHS MEDICAL ASD INC., |
| Manufacturer Street | 1265 GREY FOX ROAD |
| Manufacturer City | ST PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT-A-CATH II INTRASPINAL ACCESS SYSTEM |
| Generic Name | PORT/CATHETER, INTERNAL SUBCUTANEOUS |
| Product Code | LNY |
| Date Received | 2016-03-24 |
| Model Number | NA |
| Catalog Number | 21-1500-22 |
| Lot Number | NI |
| 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 | 1265 GREY FOX ROAD ST PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-24 |