MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2019-05-03 for BD SWAB ALCOHOL? 100 BX 1200 326895 manufactured by Bd Medical - Diabetes Care.
[145778498]
Initial reporter: address unavailable. Bd corporate address used. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145778499]
It was reported that there were 4 occurrences of product label being outdated with a bd swab alcohol? 100 bx 1200. The following information was provided by the initial reporter: product is damaged/leaking/outdated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2019-00424 |
| MDR Report Key | 8579192 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2019-03-06 |
| Date Added to Maude | 2019-05-03 |
| 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 MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD SWAB ALCOHOL? 100 BX 1200 |
| Generic Name | ALCOHOL SWAB |
| Product Code | LKB |
| Date Received | 2019-05-03 |
| Catalog Number | 326895 |
| Lot Number | 9065503 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-03 |