MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-12-23 for UNKNOWN N/A manufactured by Cook Inc.
[63227643]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[63227644]
It was reported the patient has had three total parenteral nutrition catheters replaced for the following reasons:? The blue lumen has blood back flow issue- medwatch# 1820334-2016-01557 (this report)? Replaced due to break prior to bmt- medwatch# 1820334-2016-01592. ? Occlusion the affected blue lumen where patency could not be restored with alteplase medwatch# 1820334-2016-01600. No additional information was available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[78991272]
Investigation? Evaluation: a review of the quality control and trends of the device was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly, a review of the device history record could not be conducted. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-01557 |
| MDR Report Key | 6202475 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-12-23 |
| Date of Report | 2017-05-31 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2016-12-23 |
| 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 | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | GCE |
| Date Received | 2016-12-23 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-12-23 |