MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-30 for DRAINAGE BAG 600ML DBAG600 manufactured by Angiotech Medical Device Technologies.
[1262698]
Customer reported that 2 units from a single lot (990781tbr) of 600 ml sterile drainage bag intended for use in wound drainage were found to not be sealed at the bottom of the pouch. The product was not used on a pt and did not compromise the sterile field. Use did not indicate any injury associated with the product.
Patient Sequence No: 1, Text Type: D, B5
[8315275]
The two returned complainant samples were visually evaluated and it was determined that neither pouch had evidence of a seal being formed. The lack of any visual attempt at a seal indicates that the pouches did not go through the manually operated sealing machine, which indicates the likely root cause as employee error. Employee training was conducted for the packaging dept regarding this issue and additional root cause analysis and corrective actions are in process to address prevention of this issue in the future. There was no in-house inventory of the subject lot in stock to conduct a visual examination and no additional complaints of open seals have been received for the subject lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2009-00008 |
| MDR Report Key | 1460903 |
| Report Source | 07 |
| Date Received | 2009-06-30 |
| Date of Report | 2009-05-18 |
| Date of Event | 2009-05-18 |
| Date Mfgr Received | 2009-05-18 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2010-06-01 |
| 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 | SHANNON BROOKS, SR. ANALYST |
| Manufacturer Street | 3600 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINAGE BAG 600ML |
| Generic Name | DRAINAGE BAG |
| Product Code | EXF |
| Date Received | 2009-06-30 |
| Returned To Mfg | 2009-06-18 |
| Model Number | DBAG600 |
| Catalog Number | DBAG600 |
| Lot Number | 90781TBR |
| ID Number | NA |
| Device Expiration Date | 2014-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES |
| Manufacturer Address | 3600 SW 47TH AVE GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-30 |