MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-17 for DAVIS & GECK SUTURE 2-0 MAXON NEEDLE 6233-S1 manufactured by Davis & Geck.
[2645]
While suturing patient for closure, needle tip broke off. Tip not found - x ray taken; not seen of film. Needle holder was also used - no information available concerning the identification of this device at this time. Device not 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: design - inadequate. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5167 |
| MDR Report Key | 5167 |
| Date Received | 1993-05-17 |
| Date of Report | 1993-05-03 |
| Date of Event | 1993-04-23 |
| Date Facility Aware | 1993-04-23 |
| Report Date | 1993-05-03 |
| Date Reported to Mfgr | 1993-04-26 |
| Date Added to Maude | 1993-06-29 |
| 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 | DAVIS & GECK SUTURE 2-0 MAXON NEEDLE |
| Product Code | HAS |
| Date Received | 1993-05-17 |
| Model Number | 6233-S1 |
| Catalog Number | 6233-S1 |
| Lot Number | 900326 OR 907089 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4869 |
| Manufacturer | DAVIS & GECK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-05-17 |