MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-05-04 for "D" BAG DRAINAGE SET DBAG600 manufactured by Angiotech, Medical Device Technologies.
[22094456]
The customer reported the pouch is drilled.
Patient Sequence No: 1, Text Type: D, B5
[22257316]
The product was returned for review. The seal of the pouch is complete. There is a straight cut measuring 3 inches on the poly side of the pouch. This product is packaged twenty to a box. The two flaps on the end of the box are folded over and taped. If a cutting utensil is used to open the box and is pushed deep enough while cutting the tape, the top pouch may be cut as seen on the returned pouch. This is the first report of this occurring. The defect is readily visible by the customer. We will continue to monitor and trend to take action when necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2011-00005 |
| MDR Report Key | 2097432 |
| Report Source | 08 |
| Date Received | 2011-05-04 |
| Date of Report | 2011-04-11 |
| Date of Event | 2011-04-11 |
| Date Mfgr Received | 2011-04-11 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-03-29 |
| 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 QUALITY ANALYS |
| Manufacturer Street | 3600 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523380440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "D" BAG DRAINAGE SET |
| Generic Name | DRAINAGE SET |
| Product Code | EXF |
| Date Received | 2011-05-04 |
| Returned To Mfg | 2011-04-25 |
| Model Number | DBAG600 |
| Catalog Number | NA |
| Lot Number | 030823VI |
| ID Number | NA |
| Device Expiration Date | 2015-11-30 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2011-05-04 |