MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-14 for UNKNOWN N/A manufactured by Cook Inc.
[59758193]
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59758194]
It was reported while the patient was in care of the hospice nurse, the drain hub separated from the catheter. The patient was sent to the hospital and the drain was taped off until the procedure for the replacement of the device could be performed. At the time of this report no other information was available.
Patient Sequence No: 1, Text Type: D, B5
[60772460]
(b)(4). Investigation - evaluation: since no rpn, lot number or device specific information is available, the review of the exact specifications, ifu, manufacturing, quality control documents, work orders or non-conformances could not be performed at this time. Given the note "multipurpose drain- neph drain" from the internal notes of the complaint it is reasonable to suggest the device from the complaint might be a multipurpose drainage catheter with macloc. Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user. Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure. 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 health risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[60772461]
It was reported while the patient was in care of the hospice nurse, the drain hub separated from the catheter. The patient was sent to the hospital and the drain was taped off until the procedure for the replacement of the device could be performed. At the time of this report no other information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-01283 |
| MDR Report Key | 6098776 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-14 |
| Date of Report | 2016-10-16 |
| Date of Event | 2016-10-16 |
| Date Mfgr Received | 2016-10-16 |
| Date Added to Maude | 2016-11-14 |
| 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 | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | EYB |
| Date Received | 2016-11-14 |
| 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 | 2016-11-14 |