MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-25 for BD FACS SAMPLE PREP ASSISTANT III (BD SPA III) 647205 manufactured by Tecan Systems Inc.
[4866466]
On (b)(6) 2014, tecan was notified by (b)(4) of an adverse event with the bd spa iii. Reference mfr report #2916837-2014-00001. A bd field service prep was repairing a bd spa iii at a customer site. The exit waste quick connect on the fluidics tower of the bd spa iii was broken. 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 engineers face. The engineer was immediately taken to the accident and emergency department for a (b)(6) injection and immediate (b)(6) post-exposure prophylaxis and treatment continues.
Patient Sequence No: 1, Text Type: D, B5
[11922501]
Tecan was notified of the adverse event by (b)(4) on (b)(6) 2014. (b)(4) indicated that the event was not a result of a malfunction of the instrument, but employee error in conducting the repair. No assistance or corrective action from tecan system was required by (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916719-2014-00001 |
| MDR Report Key | 4060420 |
| Report Source | 07 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-08-20 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2014-07-29 |
| Device Manufacturer Date | 2008-05-27 |
| Date Added to Maude | 2014-09-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GARY BARRON |
| Manufacturer Street | 2450 ZANKER RD. |
| Manufacturer City | SAN JOSE CA 951317126 |
| Manufacturer Country | US |
| Manufacturer Postal | 951317126 |
| Manufacturer Phone | 4089533112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 | 2014-08-25 |
| Model Number | 647205 |
| Catalog Number | 647205 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-08-25 |