MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-25 for BARD 000150 manufactured by Band Endoscopic Technologies C.b.bard. Inc..
[27436513]
Patient was undergoing on egd with dilation. Once dilation was complete, dilator and guidewire were removed. At that time, it was observed that the spring tip of the guide wire was no longer attached. The gastroscope was inserted in an attempt to retrieve the spring tip. During this time, the patient became agitated and confused, pulled at the scope, set up grasping at her neck stating "i can't breath". Resuscitation steps immediately initiated. Mfr# 1223688-2004-00033.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5124840 |
| MDR Report Key | 5124840 |
| Date Received | 2004-05-25 |
| Date of Report | 2004-05-24 |
| Date of Event | 2004-05-18 |
| Date Facility Aware | 2004-05-18 |
| Report Date | 2004-05-24 |
| Date Reported to FDA | 2004-05-25 |
| Date Reported to Mfgr | 2004-05-25 |
| Date Added to Maude | 2015-10-02 |
| 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 | 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 | BARD |
| Generic Name | MARKED SPRING TIP GUIDEWIRE |
| Product Code | NKQ |
| Date Received | 2004-05-25 |
| Catalog Number | 000150 |
| Lot Number | 22C02369 |
| ID Number | REF. #000150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAND ENDOSCOPIC TECHNOLOGIES C.B.BARD. INC. |
| Manufacturer Address | 129 CONCORD ROAD, BLDG #3 BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2004-05-25 |