MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-12 for SAMPLE CUPS, 0.5 ML 651412 manufactured by Beckman Coulter, Inc..
[2566781]
Customer reported to beckman coulter, inc. (bec) that there were some 0. 5 ml sample cups with holes in them from a bag of lot 1042839. Customer reported that the sample cups have not been used. There was no report of any erroneous results. There was no report of any adverse event or injury requiring medical intervention or patient treatment bec sent a replacement of 0. 5 ml sample cups to the customer.
Patient Sequence No: 1, Text Type: D, B5
[9531949]
Bec initial investigation after receiving the complaint indicated that the malfunction would not likely cause or contribute to death or serious injury upon recurrence. Upon further investigation, bec has determined that the malfunction might cause a delay in reporting patient results. Therefore, bec is filing this medwatch report at this time. Bec identifier for this complaint is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00120 |
| MDR Report Key | 2414352 |
| Report Source | 05,06 |
| Date Received | 2012-01-12 |
| Date of Report | 2011-08-29 |
| Date of Event | 2011-08-29 |
| Date Mfgr Received | 2011-08-29 |
| Date Added to Maude | 2012-08-01 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAMPLE CUPS, 0.5 ML |
| Generic Name | CONTAINER, SPECIMEN, NON-STERILE |
| Product Code | NNI |
| Date Received | 2012-01-12 |
| Catalog Number | 651412 |
| Lot Number | 1042839 |
| 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 | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-12 |