MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for 360" COILED MRI EXTENSION SET manufactured by Summit Medical, Inc..
[137928127]
Per the initial reporter: the mri tubing is manufactured and delivered as a loose coil? Slinky-like. Normally, during prep, the nurses will pull on the ends of the tubing to allow the tubing to stretch. This particular lot of tubing had the coils bonded together too strongly. When the nurse pulled on the tubing, it ripped. Additionally, these rips in the tubing were hard to spot during the prep. They weren? T noticed until the tubing leaked. The set was given to central supply for return to the manufacturer rep. Update from the manufacturer pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8392216 |
| MDR Report Key | 8392216 |
| Date Received | 2019-03-05 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-11-03 |
| Report Date | 2018-12-23 |
| Date Reported to FDA | 2018-12-23 |
| Date Reported to Mfgr | 2019-02-13 |
| Date Added to Maude | 2019-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 360" COILED MRI EXTENSION SET |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2019-03-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMIT MEDICAL, INC. |
| Manufacturer Address | 20 ADDISON AVE. FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-05 |