MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-08-10 for CD ENZYMATIC CLEANER 99644-01 manufactured by Abbott Diagnostics Division/celldyn.
[21395660]
The customer states that when using the enzymatic cleaner for cleaning the cell-dyn 3700 analyzer that the cleaner was sprayed into the eye and on the skin. The skin and eye were rinsed with tap water. The customer states that the skin is reddened and burns slightly and the eye is irritated. Vision in the eye was apparently unaffected with no plans to see a doctor at this time. The csc taking the call discussed the safety instructions of the material safety data sheet with the customer and advised the customer regarding its components including rinse the eye thoroughly and wash the skin with a lot of running water and soap and see a doctor if symptoms persist. No further impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[21472003]
Investigation summary: personal injury during use of enzymatic cleaner for cleaning a cell-dyn 3700. Labeling: review of the enzymatic cleaner bottle, the box insert and box label found cautions and information including; caution: irritant, harmful caution: strong proteolytic enzyme. Irritating to eyes, skin and respiratory system. Sensitizer by inhalation. Avoid direct contact with eyes and skin. Avoid breathing mist or vapor. Irritating to eyes, respiratory system and skin. May cause sensitization by inhalation. This material and its container must be disposed of in a safe way. If swallowed, seek medical advice immediately and show this container or label. A review of the cell-dyn 1700 operator's manual, l/n: 06h89-01, rev. F, page 8-4, found the hazards section states prevent exposure to chemicals used in the operation and maintenance of the cell-dyn 3700 system (including reagents) by using appropriate personal protective equipment, work procedures, and information on material safety data sheets (msds). In reviewing section 9: maintenance procedures, the instruction for all maintenance procedure have, as materials required appropriate personal protective equipment. The troubleshooting guide (section 10) also recommend personal protective equipment. A review of material safety data sheet for cell-dyn enzymatic cleaner, l/n: 99644-01 gives health hazards and first aid measures similar to that on the product labeling (bottle/box/insert). Under section 8: exposure controls and personal protective gloves, safety glasses or other protective eyewear and laboratory coat or appropriate protective clothing. The labeling further includes a box insert personal protective equipment: cell-dyn 3700 system operator's manual, 06h89-01, rev f section 8: hazards: hazards information and precautions: chemical hazards page 8-4. Section 9: maintenance: 9-19, 9-20, 9-21, 9-22, 9-24, 9-27, 9-30, 9-32, 9-34, 9-35, 9-36, 9-37, 9-40, 9-43, 9-45, 9-46, 0-48, 9-51, 9-53, section 10: troubleshooting; troubleshooting guide: p. 10-32, section 14: reticulocyte package; routine operation p. 14-67, 14-72. Trending: a review of complaint reports for the months of january 2007 through june 2007, did not indicate an adverse trend for cell-dyn enzymatic cleaner, list number 99644-01 for this issue. Conclusion: the person did not seek medical treatment for the event. The event is addressed in the device labeling with handling precautions. It was not known if the person was wearing protective equipment such as lab coat or protective eye-wear at the time of the incident. User error contributed to the event. Customer interaction/instruction/training resolved the issue. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2007-00115 |
| MDR Report Key | 891575 |
| Report Source | 01,05 |
| Date Received | 2007-08-10 |
| Date of Report | 2007-07-30 |
| Date of Event | 2007-07-30 |
| Date Mfgr Received | 2007-07-30 |
| Date Added to Maude | 2007-08-14 |
| 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 | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8749379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CD ENZYMATIC CLEANER |
| Generic Name | FOR REMOVAL OF PROTEIN BUILDUP WITHIN THE INSTRUMENT |
| Product Code | JCB |
| Date Received | 2007-08-10 |
| Model Number | NA |
| Catalog Number | 99644-01 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 869777 |
| Manufacturer | ABBOTT DIAGNOSTICS DIVISION/CELLDYN |
| Manufacturer Address | 5440 PATRICK HENRY DR. SANTA CLARA CA 95054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-10 |