MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-20 for DESERET 3812551 manufactured by Becton Dickinson.
[2700]
While gathering supplies in preparation for inserting a medlock into a patient, the iv therapist noted the presence of a foreign body within the sealed sterile wrapperdevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4151 |
| MDR Report Key | 4151 |
| Date Received | 1992-07-20 |
| Date of Report | 1992-05-21 |
| Date of Event | 1992-05-13 |
| Date Facility Aware | 1992-05-13 |
| Report Date | 1992-05-21 |
| Date Reported to Mfgr | 1992-05-20 |
| Date Added to Maude | 1993-05-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DESERET |
| Generic Name | PRN ADAPTER |
| Product Code | FKB |
| Date Received | 1992-07-20 |
| Catalog Number | 3812551 |
| ID Number | H2082D |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3884 |
| Manufacturer | BECTON DICKINSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-20 |