MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-06-22 for PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM 21-1501 manufactured by Smiths Medical Md.
[2731221]
User facility reported that during use of the loss of resistance syringe the product leaked when depressed therefore presenting a false loss of resistance. Attempts to thread epidural catheter were unsuccessful. The needle was advanced an add'l depth which led to puncture of the pt dura. The pt is reported to require treatment for a post dural puncture headache. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[10118346]
Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00256 |
| MDR Report Key | 2632408 |
| Report Source | 01,06 |
| Date Received | 2012-06-22 |
| Date of Report | 2012-06-20 |
| Date of Event | 2012-05-17 |
| Date Facility Aware | 2012-05-17 |
| Report Date | 2012-06-20 |
| Date Reported to FDA | 2012-06-20 |
| Date Mfgr Received | 2012-05-23 |
| Date Added to Maude | 2012-06-29 |
| 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 EPIDURAL IMPLANTABLE ACCESS SYSTEM |
| Generic Name | LNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2012-06-22 |
| Model Number | 21-1501 |
| Catalog Number | 21-1501 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-06-22 |