MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-08-13 for BD BBL? DRYSLIDE? PYR KIT 231747 manufactured by Bd Caribe, Ltd.
[116913435]
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
[116913436]
It was reported that while using a bd bbl? Dryslide? Pyr kit a technician received a cut from a glass ampoule that went through the packaging. The patient received medical evaluation following the incident and was monitored for fever and infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647876-2018-00021 |
| MDR Report Key | 7777327 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-08-13 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2018-03-12 |
| Date Added to Maude | 2018-08-13 |
| 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 CARIBE, LTD |
| Manufacturer Street | VICKS DRIVE LOT NO. 1 |
| Manufacturer City | CAYEY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BBL? DRYSLIDE? PYR KIT |
| Generic Name | MICROORGANISM DIFFERENTIATION AND IDENTIFICATION DEVICE |
| Product Code | JTO |
| Date Received | 2018-08-13 |
| Catalog Number | 231747 |
| Lot Number | 8071659 |
| Device Expiration Date | 2019-07-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE, LTD |
| Manufacturer Address | VICKS DRIVE LOT NO. 1 CAYEY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-13 |