MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2014-02-13 for PORT A CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical, Inc..
[19398699]
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 results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[19482778]
From clinical trial study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug on (b)(6) 2013. According to reporter, during administration of medication via the port on (b)(6) 2014, the clinician noted fullness at the port site. Following the administration of medication, the clinician withdrew the needle from the port and noted leakage of clear fluid. The leakage stopped after 2 minutes pressure application at the port site. Following observation, the patient was discharged in stable condition. Later in the day on (b)(6) 2014, the patient returned to the hospital following onset of shaking. A surgical procedure was scheduled and the device was replaced on (b)(6) 2014. No permanent adverse effects to patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183502-2014-00033 |
| MDR Report Key | 3650139 |
| Report Source | 00,06 |
| Date Received | 2014-02-13 |
| Date of Report | 2014-02-13 |
| Date of Event | 2014-01-10 |
| Date Facility Aware | 2014-01-10 |
| Report Date | 2014-02-13 |
| Date Reported to FDA | 2014-02-13 |
| Date Mfgr Received | 2014-01-17 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2014-02-28 |
| 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 | 2014-02-13 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 1882782 |
| ID Number | NA |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| 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. Required No Informationntervention | 2014-02-13 |