MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-16 for CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET C-HECS-300 manufactured by Cook Inc.
[130635815]
Lot numbers: 5 packages returned from 3 lots: 3 x 6156773, 1 x 5800528, 1 x 6063434. This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[130635816]
It was reported that over a month's time ((b)(6) to (b)(6) 2015) during testing prior to use, five concord endoscopic cholangiography catheters leaked where the syringe enters and doesn't stay connected. It was further noted that the device was leaking at the hub. No adverse effects to the patient(s) were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03822 |
| MDR Report Key | 8167898 |
| Date Received | 2018-12-16 |
| Date of Report | 2018-12-16 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2018-12-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8128294891 |
| 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 | 0 |
| Brand Name | CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET |
| Generic Name | GBZ CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2018-12-16 |
| Returned To Mfg | 2016-01-05 |
| Model Number | NA |
| Catalog Number | C-HECS-300 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-16 |