MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for BD MEDICAL BLOOD TUBING manufactured by Bd Medical Diabetes Care.
[133057662]
Blood tubing failures - product defect; 10 different events between (b)(6) - (b)(6) 2018. Date: (b)(6) 2018, 7ne, blood seeping from non-used y spike on tubing above chamber. Lot: (10)18086026, no pt harm, (b)(4). Ref #'s mw5083033, mw5083035, mw5083036, mw5083037, mw5083038, mw5083039, mw5083040, mw5083041, and mw5083042.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083034 |
| MDR Report Key | 8239496 |
| Date Received | 2019-01-10 |
| Date of Report | 2018-12-24 |
| Date of Event | 2018-11-08 |
| Date Added to Maude | 2019-01-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | BD MEDICAL BLOOD TUBING |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2019-01-10 |
| Lot Number | (10)18086026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL DIABETES CARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-10 |