MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-27 for ALL PURPOSE DRAINAGE CATHETER 756512025 manufactured by Angiotech, Medical Device Technologies.
[2235601]
Customer states that the packaging was compromised on two packages of skater drainage catheters. These devices were not used on pts, however, potential for injury exists if a non sterile device is used on a pt.
Patient Sequence No: 1, Text Type: D, B5
[9432607]
We have received a report from our distributor in (b)(4), which states during their incoming inspection they found the pouch was drilled. The lot number reported was packaged in 2008. A sales report was run for the reported lot number and it was found the product was sent to the customer in 2008. Despite continuous efforts, we have not received the product, nor pictures of the pouch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2011-00011 |
| MDR Report Key | 2273629 |
| Report Source | 06 |
| Date Received | 2011-09-27 |
| Date of Report | 2011-08-29 |
| Date of Event | 2011-08-29 |
| Date Mfgr Received | 2011-08-29 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2012-07-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHANNON BROOKS, SR. QUAL ANALYST |
| 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 | ALL PURPOSE DRAINAGE CATHETER |
| Generic Name | SKATER ALL PURPOSE DRAINAGE CATHETER |
| Product Code | GBQ |
| Date Received | 2011-09-27 |
| Model Number | 756512025 |
| Catalog Number | NA |
| Lot Number | 82901QDS |
| ID Number | NA |
| Device Expiration Date | 2013-10-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES |
| Manufacturer Address | 3600 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-27 |