MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for BD? SYRINGE HEPARIN 27GAX1.2 ML 324701 manufactured by Bd Medical - Diabetes Care.
[115678654]
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). 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
[115678655]
It was reported that bd? Syringe heparin 27gax1. 2 ml contained plastic like foreign matter. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2018-00552 |
| MDR Report Key | 7735558 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-07-11 |
| Device Manufacturer Date | 2016-03-28 |
| Date Added to Maude | 2018-07-31 |
| 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 | 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 | 0 |
| Brand Name | BD? SYRINGE HEPARIN 27GAX1.2 ML |
| Generic Name | FLUSH |
| Product Code | NZW |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-07-09 |
| Catalog Number | 324701 |
| Lot Number | 6088621 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-31 |