MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-21 for DRAINAGE BAG CONNECTOR CONNECTING TUBE CTU14.0-30-ST manufactured by Cook Inc.
[108751605]
Product code: gcd. (b)(4). Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[108751606]
It was reported four drainage bag connector connecting tubes were ordered but not received. This meant the patient scheduled to have two chest tubes placed on (b)(6) 2018 had to reschedule or go to another facility. This incident is reported as an adverse event as patient care was allegedly postponed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01522 |
| MDR Report Key | 7529379 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-21 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2018-03-12 |
| Date Added to Maude | 2018-05-21 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINAGE BAG CONNECTOR CONNECTING TUBE |
| Product Code | GCD |
| Date Received | 2018-05-21 |
| Catalog Number | CTU14.0-30-ST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-21 |