MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2005-07-27 for MILLEX-OR MILLEX - .22U SLGL0250S manufactured by Millipore Corp..
[35463745]
The product labeling for millex - or sterilizing filters clearly states 'do not use with syringes smaller than 10cc'. Unfortunately, a 2cc syringe was used during the complaint event procedure. The 2cc syringe caused the need for over tightening and fluid pressure buildup. Use of a syringe 10cc (or greater) would eliminate the need for over tightening and reduce the fluid pressure within the device assembly. Since the millex - or filter reference in (b)(4) was 'misused' according to product label statements, there is no corrective action planned at this time.
Patient Sequence No: 1, Text Type: N, H10
[35463746]
During cataract surgery, the millex-or sterilizing filter (with dispensing tip) detached from the syringe and with force was projected into the patient's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020892-2005-00001 |
| MDR Report Key | 5353249 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2005-07-27 |
| Date of Report | 2005-07-27 |
| Date of Event | 2005-05-24 |
| Date Mfgr Received | 2005-06-23 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2016-01-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN ASTARITA |
| Manufacturer Street | 80 ASHBY RD. |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7815332484 |
| Manufacturer G1 | MILLIPORE IRELAND B.V. |
| Manufacturer City | CARRIGTWOHOLL CO. CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLEX-OR |
| Generic Name | STERILIZING FILTER |
| Product Code | JRL |
| Date Received | 2005-07-27 |
| Returned To Mfg | 2005-07-01 |
| Model Number | MILLEX - .22U |
| Catalog Number | SLGL0250S |
| Lot Number | R4PN91767 |
| Device Expiration Date | 2007-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILLIPORE CORP. |
| Manufacturer Address | BILLERICA MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-07-27 |