MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-08 for BD FACS SAMPLE PREP ASSISTANT III (BD SPA III 647205 manufactured by Tecan Systems Inc.
[4709888]
On (b)(6) 2014 a (b)(6) bd field service engineer (fse) at (b)(6), dept of haematology, (b)(6) was exposed to biohazard waste during a service visit. Reported to bd biosciences on (b)(6) 2014. The exit waste quick-connect on the fluidics tower of the bd facs spa iii was broken and the engineer's visit was to resolve the situation. The male part of the fitting was jammed in the female part. The engineer proceeded to replace the female quick-disconnect mounted in the fluidics tower. Decontamination of the system by the customer was not possible due to the failure mode. Upon cutting the tubing to the fluidic fitting, residual pressure in the waste tube sprayed biohazardous waste at the engineer's face. The engineer was immediately taken to the accident and emergency dept (er) for a hepatitis b injection and immediate hiv post-exposure prophylaxis (pep) and treatment continues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916837-2014-00001 |
| MDR Report Key | 4006471 |
| Report Source | 07 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2014-07-17 |
| Device Manufacturer Date | 2008-05-27 |
| Date Added to Maude | 2014-08-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ERIC CLAUSSEN, DIR, REG COMPL |
| Manufacturer Street | 2350 QUME DR. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089546348 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD FACS SAMPLE PREP ASSISTANT III (BD SPA III |
| Generic Name | BD SPA III |
| Product Code | PER |
| Date Received | 2014-08-08 |
| Model Number | 647205 |
| Catalog Number | 647205 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SYSTEMS INC |
| Manufacturer Address | 2450 ZANKER RD SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-08 |