MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-13 for ARROW CS17702 manufactured by Arrow International.
[2954]
The patient received a blood transfusion via a cvp line with this catheter in place. Upon flushing of the line after transfusion, the catheter split distal to the blue catheter clamp. The patient required immediate removal and replacement of the cvp line and catheterdevice labeled for single use. Patient medical status prior to event: invalid data. There was not 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4213 |
| MDR Report Key | 4213 |
| Date Received | 1992-07-13 |
| Date of Report | 1992-03-12 |
| Date of Event | 1992-03-06 |
| Date Facility Aware | 1992-03-06 |
| Report Date | 1992-03-12 |
| Date Reported to Mfgr | 1992-03-12 |
| Date Added to Maude | 1993-05-17 |
| 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 | ARROW |
| Generic Name | DOUBLE LUMEN CATHETER 7 FR. 2 LUMEN 20 CM |
| Product Code | FGH |
| Date Received | 1992-07-13 |
| Model Number | NA |
| Catalog Number | CS17702 |
| Lot Number | NOT KNOWN |
| ID Number | NOT KNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3945 |
| Manufacturer | ARROW INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-13 |