MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-09-16 for COULTER AC-T 5 DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[2179209]
The customer reported one vial of the ac-t 5 diff control plus leaked from the needle hole on the cap after being pierced (unk amount of times). Further info indicated the leak only occurred when the control vial was kept in room temperature. The other vials of the same kit were intact. The potential for biohazard exposure with the reported incident was present. There was no exposure to mucous membrane or open skin lesion. No one sought medical attention. No reports of death or serious injury, and no affect to operator safety as a result of this event. The control kit was replaced for the customer.
Patient Sequence No: 1, Text Type: D, B5
[9350480]
Per labeling, beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable lab attire when operating or maintaining this or any other automated lab analyzer. Pictures of the vial were received for eval. Service was not dispatched. Root cause could not be determined based on available info. This reportable event was identified during a retrospective review conducted between jan. 1, 2008 and oct. 23, 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01453 |
| MDR Report Key | 2267024 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-16 |
| Date of Report | 2009-04-21 |
| Date of Event | 2009-04-17 |
| Date Mfgr Received | 2009-04-21 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2011-11-04 |
| 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 | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KREAMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER AC-T 5 DIFF CONTROL PLUS |
| Product Code | JPK |
| Date Received | 2011-09-16 |
| Model Number | NA |
| Catalog Number | 7547198 |
| Lot Number | 360309 |
| ID Number | NA |
| Device Expiration Date | 2009-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196250 US 33196 2500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-16 |