MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-10 for ANESTHESIA 17GAX18CM DURASAFE 401622 manufactured by Bd (suzhou).
[188672802]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188672823]
It was reported that anesthesia 17gax18cm durasafe leaked during use. The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2020-00080 |
| MDR Report Key | 9812566 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-02-15 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD (SUZHOU) |
| Manufacturer Street | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANESTHESIA 17GAX18CM DURASAFE |
| Generic Name | ADAPTER |
| Product Code | CAZ |
| Date Received | 2020-03-10 |
| Catalog Number | 401622 |
| Lot Number | 9046560 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (SUZHOU) |
| Manufacturer Address | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK SUZHOU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |