MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for AUTOMATED PC SET WITH CASSETTE 4-PRONG R5C4479C manufactured by Baxter Healthcare Corporation.
[54455896]
I noticed a pt safety problem related to a medical device (automated pd set with cassette 4-prong, code number is (b)(4)). This product has 3 holes on each side of the cassette package (total 6 holes on both sides) although there are statements on their package says "sterile", "do not use if package is damaged. " i reported and questioned the mfr about these holes which may make the sterile tubes expose to the air and contaminated during the transportation and storage, but the official response from them are", the six flutter vents (holes) is being provided for in and out of eo gas and no quality issue reported from the presence of this vents. " i cannot agree with their response based on the basic principles of the aseptic theory as well as my 20 years clinical nursing practice. Could you please investigate this pt safety issue and give me clarification regarding the quality of this medical device asap? I can be reached at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064638 |
| MDR Report Key | 5939152 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-09-01 |
| Date Added to Maude | 2016-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AUTOMATED PC SET WITH CASSETTE 4-PRONG |
| Generic Name | AUTOMATIC DELIVERY SYSTEM |
| Product Code | KCT |
| Date Received | 2016-09-01 |
| Model Number | R5C4479C |
| Lot Number | H16F17011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-01 |