MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-06-14 for BODY FLUID CONTROL 628030 manufactured by Beckman Coulter, Inc..
[2729975]
Beckman coulter warehouse in (b)(6) reported that the dxh body fluid control was leaking from the top of the second level of the body fluid control tube. The leak was noticed while control vials were still in the packing box. There was no visible damage to the package. The stain was noticed on the outside of the package. The customer was wearing personal protective equipment (ppe), including a lab coat, mask and eye shield. No one was splashed, sprayed or injured. There was no contact to open or broken skin or mucous membranes. No one sought medical attention. The material safety data sheet (msds) was reviewed. There is an exposure control plan at the facility. There was no death, injury or an effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9919712]
Field service was not requested for this event. Failure mode of this event is a loose cap on body fluid control shipment. 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 laboratory attire when operating or maintaining this or any other automated laboratory analyzer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01906 |
| MDR Report Key | 2617129 |
| Report Source | 01,08 |
| Date Received | 2012-06-14 |
| Date of Report | 2012-05-23 |
| Date of Event | 2012-05-23 |
| Date Mfgr Received | 2012-05-23 |
| Device Manufacturer Date | 2012-04-19 |
| Date Added to Maude | 2012-10-11 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN CULTER 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 | BODY FLUID CONTROL |
| Generic Name | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| Product Code | JPK |
| Date Received | 2012-06-14 |
| Model Number | NA |
| Catalog Number | 628030 |
| Lot Number | 2884700K |
| ID Number | NA |
| Device Expiration Date | 2012-07-20 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-14 |