MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-17 for COULTER? LYSE S III DIFF REAGENT (5 LITER) 8546796 manufactured by Beckman Coulter, Inc..
[2149725]
This is a follow up report. Corrected data: this mdr documents one (1) of two (2) reagents leaking upon receipt of shipment. Mdr 1061932-2011-01840 documents the other leaking reagent bottle (coulter clenz reagent, 10 liter) at this customer site.
Patient Sequence No: 1, Text Type: D, B5
[2211453]
A customer contacted beckman coulter inc. (bec) to report one (1) leaking bottle of coulter lyse s iii diff reagent (5 liter) upon receipt of shipment. The customer indicated that this incident was a shipping damage issue. The products were on a pallet and multiple products were wet from the leaking reagent. The lot number for the leaking reagent was requested; however, the package was damaged and the lot number was illegible. Since the lot number was not provided, the manufacturing and expiration date of the reagent lot is unknown. The user was wearing personal protective equipment (ppe) at the time of the incident. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds.
Patient Sequence No: 1, Text Type: D, B5
[9366379]
Service was not dispatched for this event. Replacement product was sent to the customer. 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 is not limited to, protective eyewear, gloves, and suitable laboratory analyzer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9367820]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01820 |
| MDR Report Key | 2297448 |
| Report Source | 05,06 |
| Date Received | 2011-10-17 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-09-16 |
| Date Mfgr Received | 2011-09-16 |
| Date Added to Maude | 2012-07-06 |
| 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 KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LYSE S III DIFF REAGENT (5 LITER) |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-10-17 |
| Model Number | LYSE S III DIFF REAGENT |
| Catalog Number | 8546796 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-17 |