MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for BARD 14G CANNULA REF 000330 manufactured by Bard Shannon Limited.
[138375834]
The patient was in surgery for a laparoscopic cholecystectomy. Md inserted the implant, patient? S stomach pulled back up in the chest, md pulled the needle out leaving the cannula in place. When he reinserted the needle, it appeared to shear off part of the plastic cannula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084738 |
| MDR Report Key | 8403384 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-02-26 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 14G CANNULA |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2019-03-07 |
| Catalog Number | REF 000330 |
| Lot Number | HUCX2692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BARD SHANNON LIMITED |
| Manufacturer Address | US |
| Brand Name | BARD 14G CANNULA |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2019-03-07 |
| Catalog Number | REF 000330 |
| Lot Number | HUCX2692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD SHANNON LIMITED |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2019-03-07 |