MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-02 for HAWKINS III BLN 253100 manufactured by Angiotech, Medical Device Technologies, Inc..
[1147584]
Report received: the pouch was open inside of the box.
Patient Sequence No: 1, Text Type: D, B5
[8310081]
The samples have not been returned by the customer to confirm the defect reported. This condition is caused when a needle is not fully in the pouch and runs through the sealer bars. The misaligned bars then reduce the pressure placed on the pouch. This condition has been prevented by refurbishing the machines. The defect was addressed with the packaging dept by the plant mgr and the production mgr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2009-00010 |
| MDR Report Key | 1467911 |
| Report Source | 08 |
| Date Received | 2009-07-02 |
| Date of Report | 2009-04-28 |
| Date of Event | 2009-04-28 |
| Date Mfgr Received | 2009-04-28 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-07-31 |
| 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 S.W. 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 | HAWKINS III BLN |
| Generic Name | HAWKINS III BLN |
| Product Code | GDM |
| Date Received | 2009-07-02 |
| Model Number | 253100 |
| Catalog Number | 253100 |
| Lot Number | 82741Q36 |
| ID Number | NA |
| Device Expiration Date | 2013-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES, INC. |
| Manufacturer Address | 3600 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-02 |