MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for CLAVE CONNECTOR manufactured by Hospira.
[62341925]
Patient reported that the white part of a clave connector broke off in his central iv line. He needed to have a picc line placed until he can have another central line placed. He did not save the connector and does not know the lot number and had no other information. He states the md is aware. No other adverse events reported. Reason for use: pah.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066643 |
| MDR Report Key | 6169149 |
| Date Received | 2016-12-09 |
| Date of Report | 2016-12-02 |
| Date of Event | 2016-12-01 |
| Date Added to Maude | 2016-12-13 |
| 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 |
| 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 | CLAVE CONNECTOR |
| Generic Name | CLAVE CONNECTOR |
| Product Code | GCD |
| Date Received | 2016-12-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-09 |