MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-18 for ACCU-SED?ESR BI-LEVEL CONTROL 361555 manufactured by Becton Dickinson.
[114679427]
(b)(6). The reported lot# 1823500 was not found for the reported catalog number. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114679428]
It was reported that accu-sed? Esr bi-level control had a barcode defect in which the instrument would not recognize the barcode scanned in nor manually entered. No report of injury or medical intervention. No report of blood exposure to mucous membrane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00477 |
| MDR Report Key | 7698787 |
| Date Received | 2018-07-18 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-06-25 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| 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 | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCU-SED?ESR BI-LEVEL CONTROL |
| Generic Name | ESR INSTRUMENT |
| Product Code | GKB |
| Date Received | 2018-07-18 |
| Catalog Number | 361555 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-18 |