MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-28 for DOUBLE "T" CONNECTOR W/SWIVEL MX453-2L manufactured by Medex, Inc..
[20054811]
Leadage has occurred at main connecting site. Cracks in the tubing have been observed. Ivac neonate infusion pumps or medfusion infusion pumps were in use at the time. Device labeled for single use. Patient medical status prior to event: unknown. There was multiple patient involvement. Number of patients involved: 4. 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. 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: other, hub. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3692 |
| MDR Report Key | 3692 |
| Date Received | 1992-07-28 |
| Date Reported to Mfgr | 1992-07-10 |
| Date Added to Maude | 1993-04-30 |
| 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 | DOUBLE "T" CONNECTOR W/SWIVEL |
| Generic Name | N/A |
| Product Code | FKB |
| Date Received | 1992-07-28 |
| Model Number | MX453-2L |
| Lot Number | 22C09045 AND 22B18047 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3438 |
| Manufacturer | MEDEX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-28 |