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 2011-10-20 for COULTER? LH700 SERIES RETIC PAK 8547196 manufactured by Beckman Coulter, Inc..
[2248444]
A customer reported that coulter lh700 series retic pak was leaking when received. The seal on one of the reagents was twisted, causing the leak. It is unknown which of the two reagents, reagent a or b, was leaking. The customer was wearing personal protective equipment consisting of gloves and lab coats. There was no exposure to mucous membranes or open wounds, and medical attention was not sought. The material safety data sheet (msds) was reviewed, and an exposure control or risk management plan is in place at the facility. There was no death or injury, and no patient result or treatment was affected.
Patient Sequence No: 1, Text Type: D, B5
[9314513]
No physical sign of damage, other than twisted seal, was observed. The customer disposed of the leaking reagent. The customer was provided with replacement reagent. The root cause for this event is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01888 |
| MDR Report Key | 2302423 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-09-23 |
| Date of Event | 2011-09-23 |
| Date Mfgr Received | 2011-09-23 |
| Device Manufacturer Date | 2011-05-04 |
| 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 | 0 |
| 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 AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH700 SERIES RETIC PAK |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-10-20 |
| Model Number | LH700 SERIES RETIC PAK |
| Catalog Number | 8547196 |
| Lot Number | 57163K |
| Device Expiration Date | 2012-04-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-10-20 |