MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-09-14 for MCKESSON BRANDED SCBI 73-SCS025 manufactured by Sps Medical.
[120322537]
It was reported an employee received a few abrasions on her neck after glass shattered from a self-contained steam biological indicator (bi). It was reported the employee pulled the (bi) that was still warm to the touch from the autoclave after waiting twenty minutes to crack it before transferring the bi to the incubator. When she cracked the bi it shattered and it was reported a few shards of glass caused abrasions on her neck. It was reported the employee is a new user to this device and was not wearing the correct ppe. She did not seek medical attention and is reported to be fine. This is an isolated incident, there has been no other reported events. This complaint will continue to be monitored in the sps complaint system.
Patient Sequence No: 1, Text Type: N, H10
[120322538]
It was reported an employee received a few abrasions on her neck after glass shattered from a self-contained steam biological indicator (bi).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319130-2018-00002 |
| MDR Report Key | 7878208 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-09-14 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533349 |
| Manufacturer G1 | SPS MEDICAL |
| Manufacturer Street | 31 WATER STREET #1 |
| Manufacturer City | CUBA NY 14727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCKESSON BRANDED SCBI |
| Generic Name | BIOLOGICAL INDICATOR |
| Product Code | FRC |
| Date Received | 2018-09-14 |
| Returned To Mfg | 2018-08-28 |
| Model Number | 73-SCS025 |
| Lot Number | 6743 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPS MEDICAL |
| Manufacturer Address | 31 WATER STREET #1 CUBA NY 14727 US 14727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-14 |