MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-04 for ZIP CLOSURE WITH POUCH * 4914.ORG manufactured by Medical Action Industries, Inc..
[2451139]
Lab specimen transport bags from medical action industries (catalog number 4914. Org), and other companies bags are imprinted with a large opaque orange square with 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 of 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 and often "assume" the identity of the specimen. This obviously has lead to many instances of specimen identification errors. Furthermore, the hospital staff has to take the time and effort to confirm the specimen identification. This can only be accomplished by opening the bag and removing the specimen. This action, of course, leads to staff exposure to biohazards. The simple solution to this problem would be to make the biohazard label smaller and transparent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2398741 |
| MDR Report Key | 2398741 |
| Date Received | 2012-01-04 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-09-19 |
| Report Date | 2011-09-20 |
| Date Reported to FDA | 2012-01-04 |
| Date Added to Maude | 2012-01-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| 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 BAGS |
| Product Code | LIO |
| Date Received | 2012-01-04 |
| Model Number | * |
| Catalog Number | 4914.ORG |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | * |
| 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 | 2012-01-04 |