MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-20 for HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST IMS-1373 manufactured by Crosstex Sps Medical.
[139335709]
The facility reported a dental assistant was using a biological indicator (bi) when the vial burst, resulting in glass shattering near the dental assistant's face. There is potential her eye was exposed to the contents of the vial and glass. After the bi burst, the dental assistant flushed her eyes and sought medical attention to ensure no glass particles were in her eye. She is reported to be doing fine and no additional eye irritation has been reported. Regulatory affairs made several attempts to contact the facility and was unable to confirm the details of the incident or if the user was wearing proper protective equipment during the event. The instructions for use instruct waiting 10 minutes after the vial is removed from the autoclave before activation to ensure the vial has cooled down. It is unknown if the user followed this instruction. The facility did not send product back for investigation. Crosstex sps medical quality assurance team tested 30 vials from the same lot number and could not reproduce the incident reported by the facility. This will continue to be monitored in the crosstex sps medical complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[139335710]
The facility reported a dental assistant was using a biological indicator (bi) when the vial burst, resulting in glass shattering near the dental assistant's face. There is potential her eye was exposed to the contents of the vial and glass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319130-2019-00001 |
| MDR Report Key | 8436732 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-02-26 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 31 WATER STREET #1 |
| Manufacturer City | CUBA NY 14727 |
| Manufacturer Country | US |
| Manufacturer Postal | 14727 |
| Manufacturer G1 | CROSSTEX SPS MEDICAL |
| Manufacturer Street | 31 WATER STREET #1 |
| Manufacturer City | CUBA NY 14727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14727 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST |
| Generic Name | BIOLOGICAL INDICATOR |
| Product Code | FRC |
| Date Received | 2019-03-20 |
| Model Number | IMS-1373 |
| Catalog Number | IMS-1373 |
| Lot Number | 6743 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX SPS MEDICAL |
| Manufacturer Address | 31 WATER STREET #1 CUBA NY 14727 US 14727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-20 |