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 2011-09-23 for COULTER 5C CELL CONTROL 7547124 manufactured by Beckman Coulter, Inc..
[21979621]
This reportable event was identified during a retrospective review conducted for the period between (b)(4) 2008 and (b)(4) 2010 of complaints for additional reportable events. The shape of the track inside the cap appeared to be flat with a relatively shallow groove. The other vials of this product at the site were visually examined and appeared to be satisfactory. The suspect product was replaced at the time of the event. The root cause was a vial cap with an abnormal appearance.
Patient Sequence No: 1, Text Type: N, H10
[22107649]
The customer reported that a single 5c cell control (abnormal i) vial cap came off after several punctures from the instrument. There was no material spill or leak. The vial cap groves were described as shallow and flat. The operator was wearing personal protective equipment at the time of the incident and there was no exposure to mucous membranes or open lesions. The operator did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2011-01487 |
| MDR Report Key | 2276806 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-23 |
| Date of Report | 2009-05-17 |
| Date of Event | 2009-05-15 |
| Date Mfgr Received | 2009-05-17 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-06-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER 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 5C CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-09-23 |
| Model Number | NA |
| Catalog Number | 7547124 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2009-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-23 |