MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2009-11-30 for MILLEX 33MM DURAPORE PVDF 0.22UM STERILE SLGVM33RS manufactured by Millipore Ireland Ltd.
[1517374]
A complaint was rec'd from a (b) (6) customer relating to one unit of sterile millex 33 unit 0. 22um durapore pvdf syringe filter on (b) (6) 2009. The complaint was in regards to the customer observing a hole in the membrane of the filter. Customer observed the hole prior to use - no adverse incident occurred. The unit was returned on (b) (6) with the complaint confirmed on (b) (6) 2009. The continued use of the product may present a possible health hazard, because a non-integral membrane could allow the passage of viable or non-viable contaminants to pass through the filter. As a precaution, the product from lot r8pn37631 is being recalled from the marketplace.
Patient Sequence No: 1, Text Type: D, B5
[8321563]
Device is a sterile syringe filter. A hole in the filter membrane was observed by end-user prior to use. The unit was returned and evaluated. Investigation has determined that the puncture to the membrane occurred during the mfr of this lot. Most likely root cause is that, due to the stickiness of the membranes a build up occurred on the robot handling or picking heads. If the force of the vacuum in the mould, acting on the membrane coupon and the opposite force of the coupon attached to the robot head due to the sticky build up is greater than the tensile strength of the membrane, then a section of the membrane may be ripped from the coupon. The defect was not picked up during the 100% visual human inspection. A head cleaning regime and an automated in-line vision system have been introduced into the mfg process after this lot was manufactured. Investigation has demonstrated that the vision system would have rejected this unit. As preventative actions, add'l mfg controls will be introduced including an in-line air integrity tester which will 100% integrity test all manufactured units.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020892-2009-00001 |
| MDR Report Key | 1564806 |
| Report Source | 01 |
| Date Received | 2009-11-30 |
| Date Mfgr Received | 2009-11-27 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2010-07-07 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS BORROWS |
| Manufacturer Street | 290 CONCORD RD |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9787151399 |
| Manufacturer G1 | MILLIPORE IRELAND UK |
| Manufacturer Street | TULLAGREEN CARRIGTWOHILL |
| Manufacturer City | COUNTY CORK |
| Manufacturer Country | EI |
| Single Use | 0 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLEX 33MM DURAPORE PVDF 0.22UM STERILE |
| Generic Name | JRL (UNIT, FILTER, MEMBRANE) |
| Product Code | JRL |
| Date Received | 2009-11-30 |
| Returned To Mfg | 2009-10-27 |
| Catalog Number | SLGVM33RS |
| Lot Number | R8PN37631 |
| Device Expiration Date | 2011-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILLIPORE IRELAND LTD |
| Manufacturer Address | TULLAGREEN CARRIGTWOHILL COUNTY CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-30 |