MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM 48409 manufactured by Medtronic Neurosurgery.
[95833251]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[95833252]
A health care provider (hcp) reported via a manufacturer representative (rep) that the tip of the disposable subcutaneous catheter passer broke off where you put the catheter. No other information was reported.
Patient Sequence No: 1, Text Type: D, B5
[109112505]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109112506]
Additional information received reported the catheter passer broke off at the place where it was inserted (just distal to) in a groove in the handle. It was the piece of the plastic that the catheter attaches to that pulls the catheter through the rod. There were no environmental/external/patient factors that may have led or contributed to the issue. There was no patient injury, but they just had to pass the catheter without it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2017-00661 |
| MDR Report Key | 7138050 |
| Date Received | 2017-12-21 |
| Date of Report | 2018-05-23 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2017-09-11 |
| Date Added to Maude | 2017-12-21 |
| 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 | 0 |
| Brand Name | DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM |
| Product Code | MAJ |
| Date Received | 2017-12-21 |
| Model Number | 48409 |
| Catalog Number | 48409 |
| Lot Number | E35980 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-12-21 |