MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2013-10-21 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical, Inc..
[20637902]
From (b)(4) study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug (implantation date not provided). According to report from clinical trial organizer the device was not working since (b)(6) 2013. No further details was provided regarding product issue. The treating facility determined the system would be removed from patient use (b)(6) 2013. No permanent adverse effects to patient reported.
Patient Sequence No: 1, Text Type: D, B5
[21113289]
Customer has not yet returned the device to the mfr for device evaluation. When and if the device becomes available and is returned and evaluated the mfr will file a follow up report detailing the result of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2013-00613 |
| MDR Report Key | 3449362 |
| Report Source | 00,01,06 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-10-18 |
| Report Date | 2013-10-18 |
| Date Reported to FDA | 2013-10-18 |
| Date Mfgr Received | 2013-09-20 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2013-11-06 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM |
| Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2013-10-21 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 1768497 |
| ID Number | NA |
| Device Expiration Date | 2015-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 42 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, INC. |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-10-21 |