MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for BD SYRINGE? 5ML HEPARIN 100 UNIT 306424 manufactured by Bd Medical (bd West) Medical Surgical.
[139191928]
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
[139191929]
It was reported that bd syringe? 5ml heparin 100 unit packages do not have barcodes on them. Verbatim: health professional called to report that they found two boxes where the syringe packages did not have barcode so they are unable to scan them into their inventory. Lot 827576n found "the other day" and lot 827573n found "today". She might be able to provide photos. She wonders if this is a permanent change. No patient involvement, before use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2019-00278 |
| MDR Report Key | 8429466 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-01 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2019-03-18 |
| 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 |
| 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 (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD SYRINGE? 5ML HEPARIN 100 UNIT |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NZW |
| Date Received | 2019-03-18 |
| Catalog Number | 306424 |
| Lot Number | 827573N |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-18 |