MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for ELECTRICAL UMBILICAL CABLE 2035U manufactured by Medtronic Cryocath Lp.
[30054917]
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30054918]
It was reported that prior to use, there were four electrical cables in one package and no inner or sterile packing. It was noted that the packing box was sealed with a sticker and the orientation of the sticker was observed to be positioned differently than expected. The cables were not replaced and no patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[37031815]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002648230-2015-00371 |
| MDR Report Key | 5180090 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-02 |
| Date of Event | 2015-10-02 |
| Date Mfgr Received | 2016-01-28 |
| Device Manufacturer Date | 2012-04-24 |
| Date Added to Maude | 2015-10-27 |
| 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 | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRICAL UMBILICAL CABLE |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2015-10-27 |
| Model Number | 2035U |
| Catalog Number | 2035U |
| Lot Number | 09352 |
| Device Expiration Date | 2014-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC CRYOCATH LP |
| Manufacturer Address | 16771 CHEMIN STE-MARIE KIRKLAND H9H 5H3 CA H9H 5H3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-27 |