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 2018-10-16 for CATHETER PASSER, DISPOSABLE, 60 CM 48409 manufactured by Medtronic Neurosurgery.
[123942817]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123942818]
It was reported that upon opening the box, the tip at where the catheter was being inserted was not present. A new box was opened to complete the vp shunt procedure. No patient death or injury occurred. The patient's current status was okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00501 |
| MDR Report Key | 7971451 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-10-16 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2018-10-16 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER PASSER, DISPOSABLE, 60 CM |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2018-10-16 |
| Returned To Mfg | 2018-11-14 |
| Model Number | 48409 |
| Catalog Number | 48409 |
| Lot Number | E45989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |