MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for COOK MEDICAL REF G03388 DLPN-40-25-RING manufactured by Cook Incorporated.
[97976041]
Transvaginal drain placement requested for pelvic abscess. Tvsono guided needle approach with sheathed needle performed. Difficult access due to height aka cranial level of collection and posterior anatomic location. First attempt with needle access failed as sheath popped out of the collection. Needle reinserted into sheath and access reattempted. Failure to gain access prompted exchange for the sheathed needle for a hard 18g trocar needle which was used to gain access and wire access allowed placement of transvaginal pelvic drain. Drain fell out on the inpatient floor the next day prompting of the pt and foreign body believed to be plastic piece of needle sheath identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074692 |
| MDR Report Key | 7209043 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-04 |
| Date Added to Maude | 2018-01-22 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | COOK MEDICAL |
| Generic Name | RING DRAINAGE CATHETER NEEDLESET |
| Product Code | DWO |
| Date Received | 2018-01-19 |
| Model Number | REF G03388 |
| Catalog Number | DLPN-40-25-RING |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-19 |