MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-21 for ZIP CLOSURE WITH POUCH 4914.ORG manufactured by Medical Action Industries, Inc..
[18499490]
The lab specimen transport bags from medical action industries, inc. And other companies, are imprinted with a large opaque orange square, the biohazard symbol and the word "biohazard. " when specimens are placed in these bags, the imprinting described above, often makes it impossible to read the patient information on the specimen within the bag. Therefore, throughout the entire chain of handling these specimens, the proper identification and confirmation of the specimen within these bags, is compromised. Busy hospital staff who cannot easily read the patient information on the specimen in the bags, will often "assume" the identity of the specimen. This obviously has lead to many instances of specimen identification errors. Furthermore, when the hospital staff does take the time and effort to confirm the specimen identification, this can often only is accomplished by opening the bag and removing the specimen. This action, of course, leads to staff exposure to biohazards. The simple solution to these problems would be to make the biohazard labeling on these specimen bags smaller and transparent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2270794 |
| MDR Report Key | 2270794 |
| Date Received | 2011-09-21 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-09-19 |
| Report Date | 2011-09-20 |
| Date Reported to FDA | 2011-09-21 |
| Date Added to Maude | 2011-09-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIP CLOSURE WITH POUCH |
| Generic Name | LAB SPECIMEN TRANSPORT BAG |
| Product Code | NNI |
| Date Received | 2011-09-21 |
| Model Number | 4914.ORG |
| Catalog Number | 4914.ORG |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 209 MEDEGEN DR GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-21 |